Two piece heart valves including multiple lobe valves and methods for implanting them

ABSTRACT

A heart valve assembly including an annular prosthesis implantable within a biological annulus, a prosthetic valve including a multiple lobular shape for implantation above the biological annulus, and one or more connectors for securing the prosthetic valve to the annular prosthesis. A flexible sewing cuff extends radially from the annular prosthesis that is resiliently flexible for conforming to the multiple lobular shape of the prosthetic valve to enhance a seal between the prosthetic valve and the annular prosthesis. The sewing cuff may include a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core.

BACKGROUND

Prosthetic heart valves can replace defective human valves in patients.For example, one piece valves have been suggested that include sewingrings or suture cuffs that are attached to and extend around the outercircumference of a prosthetic valve. In addition, multiple componentvalves have also been suggested that include a sewing ring that isseparate from a valve component. The sewing rings of either type ofprosthetic valve can be tedious and time consuming to secure within atarget site, i.e., within an annulus of a heart where a natural heartvalve has been removed.

For example, to implant a sewing ring within an annulus of a heart,between twelve and twenty sutures may be secured initially to tissuesurrounding the annulus. The sewing ring and/or the entire prostheticvalve may then be advanced or “parachuted” down the sutures into theannulus. Knots may then be tied with the sutures to secure the sewingring within the annulus, whereupon the sutures may be cut. Consequently,this procedure can be very complicated, requiring management andmanipulation of many sutures. The complexity of the procedure alsoprovides a greater opportunity for mistakes and requires a patient to beon cardiopulmonary bypass for a lengthy period of time.

Because the annulus of the heart may not match the circularcross-section of the sewing ring and/or prosthetic valve, the prostheticvalve may not fit optimally within the annulus. As a result, naturalblood hemodynamics through and around the valve may be impaired,resulting in clotting, possible emboli production, and eventualcalcification of the valve structure.

To address this concern, flexible sewing rings have been suggested foruse with multiple component valves. The sewing ring may be implantedwithin the annulus, e.g., using the procedure described above, i.e.,parachuted down an arrangement of sutures. The sewing ring may conformat least partially to the anatomy of the annulus. Alternatively, insteadof using sutures, it has also been suggested to drive staples throughthe sewing ring into the surrounding tissue to secure the sewing ring.

When a mechanical or prosthetic valve is then attached to the sewingring, however, the valve and sewing ring may not mate togethereffectively, e.g., if the shape of the sewing ring has been distorted toconform to the annulus, which may also impair natural bloodhemodynamics, create leaks, and/or otherwise impair performance of theprosthetic valve.

SUMMARY OF THE INVENTION

The present invention is directed to heart valves that may be implantedwithin a patient, and, more particularly, to multiple component heartvalve assemblies that may be assembled together, and to apparatus andmethods for making and implanting them.

In accordance with one embodiment, a prosthesis is provided forreceiving a prosthetic valve to replace a preexisting natural orprosthetic heart valve within a biological annulus adjacent a sinuscavity. The prosthesis may include an annular member implantable withinthe biological annulus for contacting tissue surrounding the biologicalannulus to provide an opening through the biological annulus, and asewing cuff extending radially outwardly from the annular member.Optionally, the annular member may be resiliently compressible,expandable, and/or otherwise biased for dilating the biological annulus.

In one embodiment, the sewing cuff may be conformable for at leastpartially adopting a shape of tissue above or within the biologicalannulus. In addition or alternatively, the sewing cuff may be penetrableby fasteners for securing the sewing cuff to tissue surrounding thesinus cavity. Optionally, the sewing cuff may include one or moreconformable elements, e.g., a plurality of flexible ribs and/or alattice, e.g., to enhance sealing between the prosthetic valve and theannulus member. For example, the conformable element(s) may include asilicone, foam, fabric, or other core secured within fabric to providethe sewing cuff having sufficiently flexibility to conform to yetprovide a seal against the surrounding tissue.

In accordance with another embodiment, a heart valve assembly isprovided for implantation within a biological annulus that includes anannular prosthesis implantable within a biological annulus including anannular member for contacting tissue surrounding the biological annulusand a sewing cuff. The heart valve assembly also includes a prostheticvalve, e.g., including a multiple lobular shape for implantation abovethe biological annulus.

Optionally, one or more connectors may be provided on at least one ofthe annular prosthesis and the prosthetic valve for securing theprosthetic valve to the annular prosthesis. The one or more connectorsmay secure the prosthetic valve in a predetermined orientation relativeto the annular prosthesis. For example, the one or more connectors mayinclude a clip on the annular prosthesis for engaging a portion of theprosthetic valve when the prosthetic valve is secured to the annularprosthesis. Alternatively, the one or more connectors may include one ormore latches, detents, interlocking elements on the prosthetic valveand/or the annular prosthesis.

In one embodiment, the sewing cuff may be resiliently flexible forconforming at least partially to the multiple lobular shape of theprosthetic valve and/or to the surrounding tissue, e.g., to enhance aseal between the prosthetic valve, the annular member, and/or thesurrounding tissue. In addition or alternatively, the prosthetic valve,annular member, and/or sewing cuff may include a flexible skirt forenhancing a seal between the prosthetic valve and the annularprosthesis. Such enhanced seals may facilitate implanting a prostheticvalve having a multiple-lobular shape, e.g., corresponding to thesupra-annular above a biological annulus, and an annular member having asubstantially circular shape, e.g., corresponding to the biologicalannulus.

In accordance with still another embodiment, a prosthesis is providedfor receiving a prosthetic valve that includes an annular member, alattice extending around a circumference of the annular member, and acovering on at least a portion of the lattice to promote tissueingrowth. The annular member may be sized for delivery within abiological annulus, and/or the lattice resiliently conformable withanatomy surrounding the biological annulus. In one embodiment, thelattice may include a plurality of circumferential elements extendingaround the circumference and a plurality of transverse elementsextending between the ring elements. In addition or alternatively, thelattice may include a plurality of flexible ribs extending upwardlyand/or downwardly from an annular base.

In accordance with yet another embodiment, a method is provided forimplanting a prosthetic heart valve assembly to replace a natural orprosthetic heart valve implanted within a biological annulus below asinus cavity. An annular member may be introduced into the biologicalannulus to direct tissue surrounding the biological annulus outwardly,e.g., to at least partially dilate the biological annulus. A valveprosthesis may be advanced into the sinus cavity, and secured relativeto the annular member. A flexible sewing cuff or skirt may extend aroundthe annular member that may be engaged by the valve prosthesis forenhancing a seal between the valve prosthesis and the annulus member.

In accordance with still another embodiment, a heart valve assembly isprovided for implantation within a biological annulus that includes abase member implantable within a biological annulus and a valve member.The base member may include a rim extending about the circumference, andthe valve member may include a lower edge or other element sized to beengaged with the rim to secure the valve member to the base member. Forexample, the rim may include a ridge extending upwardly from a base ofthe base member, thereby defining a space for receiving the lower edgeof the valve member therein, e.g., to create an interference fit.Alternatively, the rim may include a plurality of tabs disposed aboutthe circumference and/or extending upwardly from a base of the frame,thereby defining a space for receiving the lower edge of the valvemember therein.

In addition or alternatively, the rim may include a ramped and/ortapered surface, e.g., upper edge for guiding the lower edge of thevalve member into engagement with the rim. In addition, the lower edgeof the valve member may include a ramped and/or tapered surface, and/ormay include a plurality of tabs or other elements for engaging the rimof the base member. Optionally, the rim may be deflectable radiallyoutwardly (or inwardly) when the lower edge of the valve member isguided into engagement with the rim, the rim being biased to returnradially inwardly (or outwardly) to enhance an interference fit betweenthe rim and the valve member.

In another option, a flexible skirt may extend from the base memberand/or valve member for enhancing a seal between the valve member andthe base member when the valve member is secured to the base member. Forexample, the base member may be sufficiently flexible to conform atleast partially to the annulus of the heart, and the flexible skirt maydeform to accommodate irregularities between the valve member and thebase member, e.g., to enhance sealing between the valve member and thebase member. The flexible skirt may extend laterally from the valvemember and/or base member. For example, the flexible skirt may extendoutwardly and/or upwardly from the base member or outwardly and/ordownwardly, from the valve member, e.g., such that the flexible skirtenhances contact between the valve member and the base member. Exemplarymaterials for the flexible skirt may include foam, fabric, and/orsilicone.

In accordance with another embodiment, a heart valve assembly isprovided for implantation within an annulus of a heart that includes anannular base member and a valve member securable to the base member. Thebase member may include a circumference generally defining a plane, andmay have a multi-lobular shape about the circumference, e.g., includinglobes separated by scallops. The base member may include a resilientframe and a cuff extending around the frame about the circumstance. Theframe may be biased to have an undulating shape such that lobe portionsof the frame extend upwardly out of the plane and scallop portionsextend downwardly out of the plane.

The cuff may be penetrable by sutures adjacent the scallop portions forpulling the scallop portions upwardly across the plane when the basemember is implanted within an annulus of a heart. Thus, the undulatingshape of the frame of the base member may define an amplitude thatdecreases when the scallop portions are pulled upwardly across theplane. In an exemplary embodiment, the valve member may have amulti-lobular shape and/or may include a valve frame including acircumference and having an undulating shape about the circumferencesuch that the valve frame may nest with the frame of the base member.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1 is a perspective view of a prosthetic heart valve assembly,including a gasket member and a valve member.

FIG. 2A is a cross-sectional view of the gasket member of FIG. 1, takenalong line 2-2, being engaged with a frame of a valve member.

FIG. 2B is a cross-sectional view of an alternative embodiment of agasket member.

FIG. 3 is a perspective detail, showing an exemplary connector forsecuring a valve member to a gasket member.

FIGS. 3A and 3B are perspective details of alternative embodiments ofconnectors for securing a valve member to a gasket member.

FIG. 4 is a cross-sectional detail of a valve member including aflexible skirt extending from a frame of the valve member.

FIGS. 5A-5E are cross-sectional views of an annulus within a heart of apatient, showing a method for implanting a prosthetic heart valveassembly within the annulus.

FIG. 6 is a cross-sectional detail of a pledget for distributing forcesfrom a suture secured through tissue.

FIG. 7 is a cross-sectional view across an annulus, showing pilotsutures secured through the tissue of each nadir of the annulus.

FIG. 8 is a cross-sectional detail showing a tool for maintainingtension on a suture.

FIG. 9 is a perspective view of another embodiment of a prosthetic heartvalve assembly, including a gasket member and a valve member.

FIG. 10 is a side view of the gasket member of FIG. 9.

FIG. 11 is a perspective view of yet another embodiment of a prostheticheart valve assembly, including a gasket member and a valve member.

FIG. 12 is a bottom view of the heart valve assembly of FIG. 11 with asewing cuff and fabric covering omitted for clarity.

FIG. 13 is an exploded perspective view of the gasket member shown inFIG. 11.

FIG. 13A is a perspective view of an alternative embodiment of anannular ring that may be included in the gasket member of FIGS. 11-13.

FIG. 14 is a perspective view of a frame of the valve member of FIG. 11captured by a clip of the gasket member of FIGS. 11 and 13.

FIGS. 15A and 15B are perspective views of alternate embodiments of acore that may be provided within a sewing cuff for a heart valveassembly.

FIG. 16 is a perspective detail of a gasket member for a heart valveassembly with an overlying fabric covering partially removed.

FIG. 17A is a partially cut-away perspective view of another embodimentof a heart valve assembly, including a gasket member and a valve member.

FIG. 17B is a perspective view of the heart valve assembly of FIG. 17A,with the valve member secured to the gasket member and with the fabriccovering removed for clarity.

FIG. 17C is a top view of the valve member and gasket member of FIGS.17A and 17B, including magnets for securing the valve member to thegasket member in a predetermined angular orientation.

FIG. 18 is an exploded perspective view of the gasket member of FIGS.17A and 17B with the fabric covering removed for clarity.

FIG. 19 is a cross-section of the gasket member of FIG. 17A, taken alongline 19-19.

FIGS. 20A-20D show exemplary embodiments of baleen elements that may beincluded in the gasket member of FIGS. 17-19.

FIGS. 21A-21C are cross-sectional views of a heart, showing a method forimplanting a gasket member within a biological annulus within the heart.

FIG. 22 is a perspective view of a gasket member including a pluralityof retainer elements with pullwire-hypotube actuators that may bereceived through a valve member when the valve member is directedtowards the retainer elements.

FIG. 23 is a detail of a proximal end of a pullwire-hypotube actuator ofthe embodiment shown in FIG. 22.

FIGS. 24A-24C are perspective details of a retainer element, showing theretainer element buckling into an enlarged configuration when actuated.

FIGS. 25A and 25B are details of a retainer element having a pattern ofslots formed therein to bias the retainer element to buckle in a desiredmanner when actuated.

FIGS. 26A and 26B are front and side views, respectively, of a springelement for making a latch.

FIGS. 27A and 27B are front and side views, respectively, of the springelement of FIGS. 26A and 26B, with ends of the spring element attachedtogether to create a two-position latch.

FIGS. 28A-28C are details of the two-position latch of FIGS. 27A and 27Bbeing used to secure a valve member to a gasket member.

FIGS. 29A and 29B are side views of heart valve assemblies that includea valve member with protrusions that may engage a portion of a gasketmember.

FIG. 30A is a detail of another embodiment of a heart valve assembly,including a latch on a gasket member for engaging a frame of a valvemember.

FIG. 30B is a side view of the latch of FIG. 30A.

FIGS. 31A and 31B are front and side views, respectively, of a pivotablelatch in an open position.

FIGS. 32A and 32B are front and side views, respectively, of the latchof FIGS. 31A and 31B in a closed position.

FIG. 33 is a perspective view of a gasket member, including a pluralityof the latches shown in FIGS. 31A-32B.

FIG. 34 is a partial cross-sectional side view of a heart valve assemblyincluding the gasket member of FIG. 34 and a valve member.

FIGS. 35A and 35B are cross-sectional views of an expandable latch incompressed and expanded configurations, respectively.

FIGS. 36A-36C are perspective details of a heart valve assemblyincluding a valve member being secured to a gasket member using thelatch of FIGS. 35A and 35B.

FIGS. 37A and 37B are top and side views of an alternative embodiment ofan expandable latch.

FIG. 38A is a perspective view of a spring latch retained in an openposition by a retaining member.

FIG. 38B is a perspective view of the spring latch of FIG. 38A, with theretaining member withdrawn, and the spring latch in its closed position.

FIGS. 39A and 39B are perspective details of a heart valve assemblyincluding a valve member being secured to a gasket member using thelatch of FIGS. 38A and 38B.

FIG. 40A is a side view of a yet another embodiment of a latchconstrained in an open position by a retaining member.

FIG. 40B is a side view of the latch of FIG. 40A, with the retainingmember withdrawn, and the latch in its closed position.

FIG. 41 is a perspective view of a heart valve assembly including avalve member and a gasket member including a plurality of the latches ofFIGS. 40A and 40B.

FIGS. 42A and 42B are cross-sectional views, showing a method forsecuring the valve member to the gasket member of FIG. 41.

FIG. 43 is a cross-sectional view of an alternative embodiment of avalve member that may be included in the heart valve assembly of FIG.41.

FIG. 44 is a perspective view of another embodiment of a gasket memberthat may be used to secure a valve member to a tissue annulus.

FIG. 45 is a top view of the gasket member of FIG. 44 with a valvemember secured thereto to provide a prosthetic valve.

FIG. 46 is a cross-section of the prosthetic valve of FIG. 45, takenalong line 46-46.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning to the drawings, FIG. 1 shows an exemplary embodiment of a heartvalve assembly 10 that generally includes a base member or “gasketmember” 12 and a valve member or “crown” 14. The gasket member 12 is anannular shaped body generally defining a plane 16 and a longitudinalaxis 17 extending substantially perpendicular to the plane 16. Thegasket member 12 may have a noncircular shape within the plane 16, suchas a multiple lobular shape. In one embodiment, the gasket member 12 hasa tri-lobular shape, i.e., including three lobes 30 separated by cuspsor scallops 28. The shape may correspond generally to a cross-section ofa biological annulus within which the gasket member 12 may be implanted,as explained further below. It will be appreciated that the gasketmember 12 may define other noncircular shapes within the plane 16, e.g.,that may correspond to the anatomy of a patient within which the heartvalve assembly 10 is to be implanted.

The gasket member 12 may include an anchoring ring or frame 18 and aflexible cuff or sewing ring 20 that may extend around a periphery ofthe anchoring ring 18. The anchoring ring 18 may be substantially rigid,e.g., retaining its shape, or semi-rigid, e.g., such that the anchoringring 18 may be resiliently deformed, e.g., to conform at least partiallyto the anatomy within which the gasket member 12 is implanted. Inaddition or alternatively, the anchoring ring 18 may be elastically orsuper-elastically deformable, e.g., compressible into a smallerconfiguration, yet resiliently biased to return to the tri-lobular shapeshown when released.

The cuff 20 may simply be a layer of fabric or other material coveringat least a portion of the anchoring ring 18. For example, a layer offabric (not shown) may cover all of the anchoring ring 18 other than anyconnectors and/or bearing surfaces, e.g., for securing the crown 14 tothe gasket member 12. In addition or alternatively, as shown, the cuff20 may include a section of material extending radially outwardly fromthe anchoring ring 18. The anchoring ring 18 and cuff 20 may beintegrally formed as a single component or may be separate componentsattached to one another. In addition, the cuff 20 may be slidably orfixedly attached to the anchoring ring 18.

Turning to FIG. 2, the anchoring ring 18 may include an annular base 22,e.g., a substantially flat sheet cut or otherwise formed to define anannular shape with a circumference, which may be defined by a circular,multiple lobular, or other enclosed loop generally lying in the plane16. A rim 24 may extend from the base 22 around the circumference, e.g.,upwardly out of the plane 16. The rim 24 may define a diameter or othercross-section that is at least marginally larger than the cross-sectionof the valve member 14, as described further below. Alternatively, therim may define a diameter that is marginally smaller than thecross-section of the valve member 14.

The rim 24 may extend continuously around the circumference, e.g., alongan outer edge 22 a of the base 22. Alternatively, the rim may be definedby a plurality of tabs or other elements (not shown) extending upwardlyfrom and/or spaced apart around the circumference of the base 22. Thus,the rim 24 and base 22 may define a space 25 therebetween for receivingand/or engaging a portion of the crown 14 therein, e.g., a lower edge 36of the crown 14, as described further below.

Optionally, the rim 24 may include a ramped edge or surface for guidingthe crown 14 into engagement with the rim 24. For example, as shown inFIG. 2A, the rim 24 may terminate in an enlarged lip 26 having a roundedcross-section, thereby providing a ramped upper edge 26 a.Alternatively, the lip may have other shapes, e.g., a beveled shapedefining a rounded or straight inclined upper edge, such as the inwardlybeveled edge 26 a′ shown in FIG. 2B. The ramped upper edge mayfacilitate aligning and/or guiding the crown 14 into proper orientationand/or into engagement with the anchoring ring 18, as explained furtherbelow.

With continued reference to FIG. 2A, at least a portion of the rim 24,e.g., adjacent the upper edge 26 a of the rim 24, may be deflectablerelative to the base 22, e.g., to facilitate insertion and/or engagementwith the crown 14. As shown, the rim 24 may be deflectable radiallyoutwardly relative to the base 22, e.g., when the lower edge 36 of thecrown 14 is guided into the space 25 defined by the rim 24. The rim 24may be resilient, e.g., elastic or superelastic, such that the rim 24 isbiased to return radially inwardly, e.g., for enhancing an interferencefit between the rim 24 and the crown 14.

Optionally, the gasket member 12 may include one or more detents orother connectors for securing the crown 14 to the gasket member 12 inaddition to or instead of the rim 24. For example, as shown in FIG. 3,the anchoring ring 18 may include a plurality of fingers 50 that extendupwardly, e.g., from the outer edge 22 a of the base 22. Each finger 50may end in a bent tip 52 that includes one or more notches 54 therein.As shown, the bent tip 52 extends inwardly substantially parallel to theplane 16 such that the notch(es) 54 extends over the base 22 below.Alternatively, the bent tip 52 may extend downwardly, e.g., back towardsthe base 22, to provide a guide for the crown 14 (not shown). In anotheralternative, shown in FIG. 3A, the finger 50′ may be formed from alength of wire, bent to provide a bent tip 52.′ Optionally, as shown inFIG. 3B, a wire finger 50″ may be provided that includes a knob or catch53″ on the bent tip 52.″ In addition or alternatively, other connectorsmay be provided, such as those disclosed in application Ser. No.10/765,725, the entire disclosure of which is expressly incorporated byreference herein.

Returning to FIG. 1, the crown 14 generally includes an annular shapedbody or frame 32 and one or more valve elements. The frame 32 may have anoncircular, e.g., multiple lobular shape, e.g., complementary to thegasket member 12. For example, the crown 14 may have a tri-lobularshape, similar to the gasket member 12, including three lobes 40separated by cusps or scallops 38. In an exemplary embodiment, the crown14 is a prosthetic valve member, i.e., an annular frame 32 carrying aplurality of tissue leaflets (not shown for clarity) extending from theframe 32, e.g., attached to commissures 34. The frame 32 may include aplurality of struts (also not shown for clarity) that may be attached toand/or otherwise carry the leaflets. For example, the struts may includea laminate structure, including two or more sheets of flexible material,similar to the struts disclosed in U.S. Pat. No. 6,371,983, the entiredisclosure of which is expressly incorporated by reference herein.

Alternatively, the crown 14 may be a connecting device to which a valve(not shown) may be connected or that may otherwise receive a valvecomponent, such as the connection adapter elements shown in co-pendingapplication Ser. No. 10/646,639, filed 22 Aug. 2003, the entiredisclosure of which is expressly incorporated by reference herein. Inanother alternative, the crown 14 may include a mechanical valve orother valve (not shown), such as those disclosed in application Ser. No.10/765,725, incorporated by reference above.

As best seen in FIG. 2A, the frame 32 may include a lower edge 36 thatdefines a diameter or other cross-section, e.g., similar to thecross-section of the rim 24. The lower edge 36 may be continuous or maybe defined by a plurality of tabs spaced about the circumference of theframe 32. As shown, the cross-section of the lower edge 36 may bemarginally smaller than the rim 24 such that the lower edge 36 may beinserted into the rim 24 to at least partially secure the crown 14 tothe gasket member 12. Alternatively, the lower edge 36 may be marginallylarger than the rim 24 such that the lower edge fits over the rim 24,yet provides a desired interference fit.

Thus, the lower edge 36 may fit into the space 25 defined by the rim 24and base 22 yet sufficiently bear against the rim 24 such that the crown14 may be secured to the gasket member 12 by the friction between thelower edge 36 and the rim 24. Optionally, as shown in FIG. 2B, the loweredge 36′ of the frame 32′ may be ramped similar to the rim 24,′ e.g., tofacilitate insertion and/or engagement between the lower edge 36′ andthe rim 24.′

The frame 32 of the crown 14 may be formed from one or more sheets ofmaterial rolled or otherwise formed such that the width of the sheetextends parallel to the longitudinal axis 17. Thus, the lower edge 36may simply be the edge of the sheet that lies generally within the plane16. Alternatively, the lower edge 36 may be a corner, e.g., where twosurfaces of the frame 32 meet.

In addition or alternatively, the frame 32 and/or other component of thecrown 14 may include one or more connectors for securing the crown 14 tothe gasket member 12. For example, as shown in FIG. 3, the crown 14 mayinclude one or more sutures 56 with slip knots 58 that may receivecorresponding fingers 50 on the gasket member 12. For each connector,the slip knot 58 may be provided by a suture, thread or other filament59 spaced apart from the corresponding suture 56 by a predetermineddistance, e.g., greater than a width of the fingers 50. When the crown14 is directed into contact with the gasket member 12, each finger 50may be directed inwardly, e.g., using a tool (not shown), until the benttip 52 is received through a corresponding suture 56 and filament 59.Alternatively, the finger(s) 50 may be biased inwardly but may bedeflected outwardly, e.g., by a tool (not shown) or by ramping the benttip(s) 52 downwardly, such that the finger(s) 50 may be resilientlymoved out of the way as the crown 14 is engaged with the gasket member12.

With the notch(es) 54 aligned with the filament 59, the suture 56 may bepulled, the resulting tension causing the slip knot 58 to tighten aroundthe bent tip 52, e.g., until a portion of one or both of the filament 59and the suture 56 are received within the notch(es) 54. The suture 56may then be knotted or otherwise tied off, and/or cut to secure thecrown 14 to the gasket member 12. Similar methods may be used to securethe fingers 50′ and 50″ shown in FIGS. 3A and 3B within the slip know58, thereby capturing the bent tip 52′ and/or knob 53″ within the slipknot 58.

Components of the heart valve assembly 10 (or other embodimentsdescribed herein), e.g., the anchoring ring 18 and/or sewing ring 20 ofthe gasket member 12, and/or the frame 32 and/or struts of the crown 14,may be made from one or more materials, such as an alloy of stainlesssteel, nickel titanium (“Nitinol”), cobalt-chrome (e.g., ELGILOY® fromElgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter MetalsCorp., Wyomissing, Pa.), molybdenum (e.g., molybdenum TZM alloy, asdisclosed, for example, in International Publication No. WO 03/082363A2, published 9 Oct. 2003, the entire disclosure of which is expresslyincorporated by reference herein), and/or tungsten-rhenium (e.g., asdisclosed in International Publication No. WO 03/082363, the entiredisclosure of which is also expressly incorporated by reference herein).In addition or alternatively, the components may be made from polymers,such as polyester (e.g., DACRON® from E. I. Du Pont de Nemours andCompany, Wilmington, Del.), polypropylene, polytetrafluoroethylene(PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon,polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris,France), aliphatic polyether polyurethanes (e.g., TECOFLEX®) fromThermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride(PVC), polyurethane, fluorinated ethylene propylene (FEP), and/orthermoplastics. In addition or alternatively, the components may includeother materials, such as extruded collagen, silicone, echogenic,radioactive, radiopaque material or combinations thereof. Exemplaryradiopaque materials that may be used include barium sulfate, titanium,stainless steel, nickel-titanium alloys, tantalum, and/or gold.

The components of the heart valve assembly 10 may be manufactured usingmethods known to those skilled in the art. For example, these methodsmay include molding, machining, casting, forming (e.g., pressureforming), crimping, stamping, melting, screwing, gluing, welding, diecutting, laser cutting, electrical discharge machining (EDM), etching,or combinations thereof.

Any or all components of the heart valve assembly 10 (or otherembodiments described herein), for example, the cuff 20, may include amatrix for cell ingrowth, a fabric, or other flexible material, e.g., afabric covering 21, as shown in FIG. 2A. The fabric or other coveringmay act as a matrix for cell ingrowth, and/or may be easily penetratedwith a needle and/or a fastener, e.g., used to attach the cuff 20 to anannulus within which the heart valve assembly 10 is implanted. Exemplaryfabric material may include polyester (e.g., DACRON® from E. I. du Pontde Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE,nylon, extruded collagen, silicone, and/or combinations thereof.Optionally, the cuff 20 may be an o-ring, or may include a cushionedmaterial, double velour material, and the like, attached using glue orother adhesives and/or fasteners. Similarly, all or a portion of thecrown 14 may also include such a matrix, such as a fabric covering 37,as shown in FIG. 2A. Methods for covering all or components of the heartvalve assembly 10 may include sintering, spray coating, adhesion, loosecovering, dipping, or combinations thereof.

For example, the anchoring ring 18 may be at least partially coveredwith fabric 21, e.g., to enhance tissue ingrowth. The fabric 21 maycover all surfaces of the anchoring ring 18 or may cover only thoseareas not intended to contact the crown 14, e.g., the surfaces intendedto provide an interference fit or including connectors for securing thecrown 14. The fabric 21 may be part of the cuff 20 or the cuff 20 may beattached to the fabric 21. Similarly, the frame 32 and/or any struts(not shown) of the crown 14 may also be at least partially covered withfabric 37. In addition to enhancing tissue ingrowth, such fabric 37 mayalso provide a desired degree of flexibility of the components of thecrown 14, e.g., allowing components to move without fatigue.

As shown in FIG. 2A, the fabric 37 may also be shaped to provide aflexible skirt 42 around at least a portion of the crown 14. Forexample, fabric may be folded over on itself to provide a skirt 42defined by a double thickness of fabric that extends from the frame 32.The skirt 42 may be free to move and/or conform, e.g., when the crown 14is secured to the gasket member 12, as described further below.Optionally, the space between the double thickness of fabric may befilled with flexible material 43, e.g., foam, fabric, silicone, and thelike, which may be provide a self-supporting shape for the skirt 42, yetmay be sufficiently flexible and/or deformable to conform as desired.Alternatively, the skirt 42 may be defined by a single layer of fabricand/or other flexible material (not shown) attached to or otherwiseextending from the frame 32 and/or fabric 37.

The skirt 42 may extend laterally from the frame 32, e.g., outwardly andupwardly as shown. Optionally, the skirt 42 may be sufficiently large toat least partially overlap the cuff 20, e.g., such that sutures orfasteners (not shown) may be received through both the skirt 42 and thecuff 20, as explained further below. Alternatively, as shown in FIG. 4,a skirt 42′ may be provided that extends outwardly and downwardly fromthe frame 32. When the crown 14 is directed into contact with the gasketmember 12 (not shown), the skirt 42′ may contact the gasket member 12before the frame 32, e.g., to enhance a seal between the crown 14 andthe gasket member 12. In another alternative, the skirt 42 may extendsubstantially perpendicular to or otherwise transversely relative to thelongitudinal axis 17.

In addition or alternatively, a flexible skirt (not shown) may beprovided on the gasket member 12, similar to the embodiments describedfurther below, e.g., to further enhance a seal between the crown 14 andthe gasket member 12. Such a skirt may extend inwardly, outwardly,and/or upwardly to contact the crown 14 as it is engaged with the gasketmember 12.

Optionally, the gasket member 12 and/or crown 14 may include one or moreguide markers (not shown), e.g., to facilitate aligning the crown 14with the gasket member 12, such as those disclosed in application Ser.No. 10/765,725, incorporated by reference above, and application Ser.No. 10/327,821, filed Dec. 20, 2002, the entire disclosure of which isalso expressly incorporated by reference herein. The guide markers mayprovide a visual indication (e.g., directly and/or using an imagingapparatus), an auditory indication, and/or a tactile indication of therelative orientation and/or location of the crown 14 with the gasketmember 12, e.g., about the longitudinal axis 17. In addition oralternatively, the gasket member 12 and/or crown may include cooperatingguides for facilitating orientation and/or engagement of the crown 14 tothe gasket member 12. For example, one of the gasket member 12 and/orcrown 14 may include one or more grooves or slots and the other mayinclude one or more corresponding tabs or ridges that allow the crown 14to be engaged with the gasket member 12 in a predetermined orientation,e.g., to facilitate aligning the multi-lobular shapes of the crown 14and gasket member 12. Exemplary guide elements are disclosed inco-pending application Ser. No. 10/327,821, incorporated by referenceabove.

Optionally, the heart valve assembly 10 (or other embodiments describedherein) and/or any fabric or other materials therein may be filledand/or coated with one or more agent delivery matrices known to thoseskilled in the art, e.g., therapeutic agents, and/or diagnostic agents.For example, any components, sub-assemblies, or the entire heart valveassembly 10 may be coated, e.g., by dip-coating or spray-coating methodsknown to one having ordinary skill in the art, utilizing materials suchas PTFE, polyester, gelatin, gel, other polymers or combinationsthereof. An exemplary method for coating a medical device for vascularuse is disclosed in U.S. Pat. No. 6,358,556 by Ding et al., the entiredisclosure of which is expressly incorporated by reference herein. Timerelease coating methods may also be used to delay the release of anagent in the coating. The agents may include one or more of radioactivematerials, radiopaque materials, cytogenic agents, cytotoxic agents,cytostatic agents, thrombogenic agents, lubricious and/or hydrophilicmaterials, anti-inflammatory agents, immunosuppressive agents, and thelike. Examples of other agents that may be used are disclosed in Waltonet al, Inhibition of Prostoglandin E₂ Synthesis in Abdominal AorticAneurysms, Circulation, Jul. 6, 1999, 48-54; Tambiah et al, Provocationof Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae,Brit. J. Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracyclineby Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis,Brit. J. Surgery 86 (6), 771-775; Xu et al, Sp1 Increases Expression ofCyclooxygenase-2 in Hypoxic Vascular Endothelium, J. BiologicalChemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruptionof Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development ofExperimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105(11), 1641-1649. The entire disclosures of these references and anyothers cited therein are expressly incorporated by reference herein.

Turning to FIGS. 5A-5E, an exemplary method is shown for implanting aprosthetic heart valve assembly, such as the heart valve assembly 10described above, within a biological annulus 90. Alternatively, othermethods may be used, such as those described elsewhere herein forimplanting the heart valve assembly 10 (or other embodiments describedherein). The annulus 90 may be the site for replacement of an existingnatural or previously implanted heart valve, such as a tricuspid,mitral, aortic, or pulmonary valve within a patient's heart (not shown).The annulus 90 may have multiple, for example two or three natural lobes92 (three lobes being shown in FIG. 5A with one lobe cut-away). Althoughthe method described below refers generally to the heart valve assembly10 shown in FIG. 1, it will be appreciated that any of the componentsdescribed herein may be implanted using similar procedures.

Before implanting the heart valve assembly 10, the patient may beprepared for the procedure using known methods. For example, the patientmay be placed on cardiopulmonary bypass (CPB), and the patient's heartmay be exposed, e.g., by sternotomy, thoracotomy, or other open orminimally invasive procedure. An incision may be created in the bloodvessel above the valve being replaced (not shown), e.g., the aorta foran aortic valve replacement, in order to access the annulus 90. Theexisting natural or prosthetic heart valve (also not shown) may beremoved from the annulus 90 using known methods.

As shown in FIG. 5A, a plurality of pilot sutures 94 may be securedthrough tissue surrounding the annulus 90. For example, usingconventional methods, a needle (not shown) may be used to deliver eachpilot suture 94 through the tissue surrounding the annulus 90. Once eachpilot suture 94 is secured through the surrounding tissue, both ends ofeach pilot suture 94 may be maintained outside the annulus, and may besecured together, e.g., to a single needle to facilitate advancing therespective suture 94 through one or more components of the heart valveassembly 10, as described further below. Other methods may also be usedfor delivering the pilot sutures or other threads or filaments throughthe tissue surrounding the annulus 90.

If desired, as shown in FIG. 6, a pledget 98 may be advanced over orotherwise delivered via each pilot suture 94. The pledget 98 maydistribute tensile forces applied, e.g., by pulling the suture 94, overa larger surface of the tissue. Thus, the pledget 98 may prevent thepilot suture 94 from tearing through or otherwise damaging the tissuewithin the pilot suture 94.

Returning to FIG. 5A with additional reference to FIG. 7, in oneembodiment, a pilot suture 94 is secured through each of the nadirs 96of the annulus 90. Thus, for a tricuspid annulus, such as the aorticvalve annulus shown in FIG. 7, three pilot sutures 94 may be securedthrough the respective three nadirs 96 of the annulus 90. It will beappreciated that other quantities of sutures (not shown) may be securedwithin the annulus, e.g., two or more in each nadir or distributedevenly or in another configuration around the annulus 90.

Turning to FIG. 5B, with the desired number of pilot sutures 94 securedto the annulus, a gasket member 12 may be advanced into the annulus 90via the pilot sutures 94. The gasket member 12 may be selected basedupon the anatomy encountered, e.g., having a plurality of lobes 30matching the lobes 92 of the annulus 90 and/or having a diameter orother cross-sectional dimension corresponding to the interiorcross-section of the annulus 90. Optionally, the base member 12 may beimplanted above the natural valve annulus, e.g., within the enlargedspace above a natural valve annulus. This configuration may allow alarger heart valve assembly 10 to be implanted, thereby maximizing theopen area through which blood may flow through the implantation site.

The pilot sutures 94 may be directed through the cuff 20 of the gasketmember 12 and the gasket member 12 may be advanced or “parachuted” downthe pilot sutures 94 into the annulus 90. For example, the pilot sutures94 may be driven through the fabric of the cuff 20 using a needle orother tool (not shown) such that the free ends of the pilot sutures 94remain outside the patient's body. Alternatively, the anchoring ring 18or other component of the gasket member 12 may include a plurality ofopenings, tubes, or other elements (not shown) for guiding or otherwiseaccommodating the sutures 94 therethrough, such as those disclosed inapplication Ser. No. 10/765,725, incorporated by reference above.

The pilot sutures 94 may be distributed around the circumference of thegasket member 12 in a desired configuration. For example, if a singlepilot suture 94 is secured through each nadir 96, the pilot sutures 94may be advanced through the cuff 20 (or anchoring ring 18) adjacentrespective cusps 28 (not shown, see FIG. 1) of the gasket member 12.Thus, as the gasket member 12 is advanced down the pilot sutures 94, thegasket member 12 may automatically align itself with the orientation ofthe annulus 90, e.g., such that the lobes 30 of the gasket member 12 arereceived in the lobes 94 of the annulus 90 and the cusps 28 are receivedover or within the nadirs 96.

Turning to FIG. 5C (in which the pilot sutures 94 are omitted forclarity), a plurality of fasteners may be directed through the gasketmember 12 into the tissue surrounding the annulus 90, e.g., to securethe gasket member 12 within the annulus 90. For example, fasteners 99may be driven through the cuff 20 of the gasket member 12 into thesurrounding tissue, e.g., distributed generally evenly around thecircumference of the gasket member 12. Exemplary fasteners that may beused and apparatus and methods for delivering them are disclosed in U.S.Pat. No. 6,402,780 and in co-pending application Ser. No. 10/681,700,filed Oct. 8, 2003. The disclosures of these references and any otherscited therein are expressly incorporated by reference herein.

Optionally, to enhance securing the gasket member 12 within the annulus90, the pilot sutures 94 may be pulled to apply tension to the tissuethrough which the pilot sutures 94 are secured. For example, as shown inFIG. 7, the nadirs 96 of the annulus 90 may have a tendency to collapseand/or at least partially occlude the annulus 90. Applying tension tothe pilot sutures 94 may open the annulus 90 and/or pull the tissue ofthe nadirs 96 into apposition with the gasket member 12.

Turning to FIG. 8, in one embodiment, a tubular member or tool 60 may beadvanced over each pilot suture 94 until a distal end 62 of the tool 60contacts the cuff 20 at the location where the pilot suture 94 has beendirected through the cuff 20. The tool 60 may be a substantiallyenclosed tube having sufficient length to extend from outside thepatient into the annulus 90. Alternatively, the tool 60 may be a “C”shaped tube whose longitudinal edges (not shown) overlap or abut oneanother, thereby defining a lumen 61 through which a pilot suture 94 maybe disposed. For example, a pilot suture 94 may be advanced into thedistal end 62 of the tool 60 until it exits a proximal end 63 of thetool 60. Alternatively, if the tool 60 has a “C” shaped cross-section,the pilot suture 94 may be forced transversely between the longitudinaledges into the lumen 61.

Each pilot suture 94 may then be pulled, or, otherwise, sufficienttension may be applied to the pilot suture 94 to pull the underlyingtissue 90 a into substantial contact with the cuff 20. A clamp 64 maythen be applied to prevent the pilot suture 94 and tool 60 from movingrelative to one another. For example, as shown in FIG. 6, a clamp 64 maybe applied transversely across the free ends 94 a of the pilot suture 94extending from the proximal end 63 of the tool 60. Alternatively, aclamp or other device may be clamped around the proximal end 63 of thetool 60, e.g., to crimp the tool 60 down onto the pilot suture 94. Thus,the free ends 94 a of the pilot suture 94 may be secured relative to thetool 60, thereby preserving the desired tension. The tool 60 may then bereleased, freeing the user's hands for other tasks during the procedure,e.g., driving the fasteners 99 through the cuff 20 into the tissue 90 a.

Once sufficient fasteners 99 are installed, the clamp 64 and tool 60 maybe removed, e.g., to release the free ends 94 a of the pilot sutures 94.

Alternatively, the pilot sutures 94 may be eliminated and the gasketmember 12 may be carried using a tool (not shown) into the annulus 90,whereupon a plurality of fasteners 99 may be delivered through thegasket member 12 into the tissue surrounding the annulus 90. Optionally,the tool may include an element (not shown) for presenting the tissue toenhance engagement of the fasteners 12 through the gasket member 12 intothe tissue or a separate tool (also not shown) may be introduced intoannulus 90 to present the tissue or otherwise enhance delivery of thefasteners 99.

Turning to FIG. 5D, a crown 14 may be advanced into the annulus 90, e.g.via the pilot sutures 94 until the crown 14 contacts the gasket member12. For example, the needle or other tool (not shown) may be used todirect the pilot sutures 94 through the crown 14, e.g., through thefabric covering 37 (not shown, see FIG. 2A) and/or through correspondingopenings or other receiving elements in the frame 32. Similar to thegasket member 12, the pilot sutures 94 may be directed throughpredetermined locations on the crown 14 to facilitate orienting thecrown about longitudinal axis 17 relative to the gasket member 12 andannulus 90. For example, the pilot sutures 94 may directed through thecrown 14 adjacent to the cusps 38 similar to the locations in the gasketmember 12.

As the crown 14 is advanced into contact with the gasket member 12within the annulus 90, the crown 14 may automatically dock into thegasket member 12. For example, as described above with reference to FIG.2A, the gasket member 12 may include a rim 24 that engages a lower edge36 of the crown 14 as the crown 14 docks into (or around) the gasketmember 12. The interference fit between the lower edge 36 and the rim 24may provide sufficient connection to secure the crown 14 to the gasketmember 12.

In addition or alternatively, as described above with respect to FIG. 3,the gasket member 12 may include a plurality of fingers 50 that may bereceived in loops defined by sutures 56 and a slip knot 58. Once thefingers 50 are properly received, the sutures 56 may be pulled totighten the slip knot 58, whereupon the sutures 56 may be tied orotherwise secured. The sutures 56 may then be cut or otherwise removedfrom the patient's body. In further options, the crown 14 and/or gasketmember 12 may include one or more other connectors, such as thosedisclosed in application Ser. No. 10/765,725, incorporated by referenceabove. Such connectors may used together to provide redundantconnections.

Turning to FIG. 5E, in addition or alternatively, the pilot sutures 94may be used to secure the crown 14 to the gasket member 12. For example,once the crown 14 is seated sufficiently against the gasket member 12,one or more knots may be directed down each pilot suture 94, similar toknotting procedures used during conventional heart valve replacement.Once sufficient numbers of knots are tied off for each of the pilotsutures 94, the loose portions of the pilot sutures 94 may be cut andremoved from the patient's body. In yet another option, clips, staples,or other fasteners (not shown) may be delivered through a portion of thecrown 14, which may also penetrate through the gasket member 12, intothe surrounding tissue.

Alternatively, if the pilot sutures 94 are eliminated, the crown 14 maybe carried into the annulus 90 using a tool (not shown), whereupon thecrown 14 may be attached or otherwise secured to the gasket member 12using any of the methods described herein.

In a further alternative, if the crown 14 does not already includeleaflets, leaflets (not shown) may be attached to the crown 14 and/orthe base member 12, for example, as disclosed in U.S. Pat. No.6,371,983, incorporated by reference above. In a further alternative, ifthe crown 14 is an intermediate connector, a separate valve member (notshown) may be introduced into the annulus 90 and attached to the crownand/or base member. For example, the crown, the base member, and/or thevalve member may include guides and/or cooperating connectors fororienting the valve member and/or attaching it to the crown and/or basemember, as will be appreciated by those skilled in the art.

Optionally, if it is desirable to remove all or part of the heart valveassembly 10, the crown 14 may be detached and/or removed (not shown)from the base member 12. For example, if the crown 14 is secured byknotting the pilot sutures 94, scissors or another tool (not shown) maybe introduced into the annulus 90 to cut the pilot sutures 94. If thefingers/slip knot connectors are used, they may also be cut in a similarmanner. In addition or alternatively, if other connectors are used, atool (not shown) may be introduced into the annulus 90 to disengage theconnectors.

Once the pilot sutures 94 are cut and/or other connectors aredisengaged, the crown 14 may then be removed from the gasket member 12,e.g., using a holder or other tool (not shown), and withdrawn from theannulus 90. Any interference fit between the crown 14 and gasket member12 (as described above with reference to FIGS. 2A and 2B, may simply beovercome by applying sufficient force using the holder or other tool.Optionally, the base member 12 may also be removed, e.g., by removingthe fasteners 99 securing the base member 12 to the annulus 90.

A replacement crown or an entire heart valve assembly (not shown) may beimplanted within the annulus 90 using similar procedures described abovefor the original crown 14. If pilot sutures are used to deliver and/orsecure the crown 14, a plurality of new pilot sutures may be securedthrough the cuff of the gasket member or through the tissue surroundingthe annulus 90, similar to the procedures described above.

Turning to FIGS. 9 and 10, another embodiment of a heart valve assembly110 is shown that includes a gasket member 112 and a crown 114. Similarto the previous embodiment, the gasket member 112 may include ananchoring ring 118 and a cuff 120, and the crown 114 may a frame 132 anda plurality of leaflets 133. Also, similar to the previous embodiments,the anchoring ring 118 includes a circumference generally defining aplane 116 and a longitudinal axis 117. The anchoring ring 118 may alsohave a multi-lobular shape about the circumference, including lobes 130separated by scallops or cusps 128.

Unlike the previous embodiments, the anchoring ring 118 may be biased tohave an undulating shape around the circumference that alternatelyextends above and below the plane 116. In one embodiment, where theanchoring ring 118 has a multi-lobular shape, the lobe portions 130 mayextend upwardly out of the plane 116, and the scallop portions 128 mayextend downwardly out of the plane 116. For example, the anchoring ring118 may have a shape corresponding to the commissures and/or nadirs ofan annulus of a natural valve that is being replaced. As best seen inFIG. 10, the undulating shape of the anchoring ring 118 may define anamplitude “A” in a relaxed state. The anchoring ring 118 may besufficient resilient, however, that the amplitude “A” may decrease orincrease, e.g., as the lobe portions 130 and/or scallop portions 128 aredirected towards or away from the plane 116, as explained further below.

Returning to FIG. 9, the crown 114 generally includes an annular shapedbody or frame 132 and one or more valve elements 133. The frame 132 mayhave a noncircular, e.g., multiple lobular shape, complementary to thegasket member 112. For example, the crown 114 may have a tri-lobularshape, similar to the gasket member 112, including three lobes 140separated by cusps or scallops 138. The frame 132 may have an undulatingshape alternating between adjacent lobe portions 140 and scallopportions 138, defining an amplitude. In one embodiment, in their relaxedstates, i.e., when free from external forces, the amplitude of the frame132 of the crown 114 may be less than the amplitude “A” of the anchoringring 118 of the gasket member 112.

In an exemplary embodiment, the crown 114 is a prosthetic valve member,i.e., an annular frame 132 carrying a plurality of tissue leaflets 13extending from the frame 132, e.g., attached to commissures 134. Theframe 132 may include a plurality of struts (not shown for clarity),which may be attached to and/or otherwise carry the leaflets, similar tothe previous embodiments.

Optionally, the gasket member 112 and/or crown 114 may include one ormore detents or other connectors (not shown) for securing the crown 114to the gasket member 112, similar to the previous embodiments. Thegasket member 112 and/or crown 114 may include fabric coverings or othermatrices, coatings, and/or guides, also similar to the previousembodiments.

The heart valve assembly 110 may be implanted within a biologicalannulus, similar to the previous embodiments. Initially, a plurality ofpilot sutures may be secured through tissue surrounding the annulus (notshown). For example, a pilot suture may be secured through each of thenadirs of the annulus. With the desired number of pilot sutures securedto the annulus, the gasket member 112 may be advanced into the annulusvia the pilot sutures, similar to the previous embodiments. A pluralityof fasteners may be directed through the gasket member 112 into thetissue surrounding the annulus to secure the gasket member 112 withinthe annulus.

To enhance securing the gasket member 112 within the annulus, the pilotsutures may be pulled to apply tension to the tissue through which thepilot sutures are secured, e.g., to open the annulus and/or pull tissueinto apposition with the gasket member 112 while the fasteners aredelivered. In addition, while tension is applied to the pilot sutures,the scallop portions 128 of the anchoring ring 118 may be drawnupwardly, thereby compressing the gasket member 112 slightly, i.e.,reducing the amplitude of the anchoring ring 118.

The crown 114 may then be advanced into the annulus, e.g. via the pilotsutures until the crown 114 contacts the gasket member 112. With thegasket member 112 compressed slightly, the undulating shape of the crown114 may substantially match the undulating shape of the gasket member112, which may facilitate docking the crown 114 to the gasket member112. Similar to the previous embodiments, as the crown 114 is advancedinto contact with the gasket member 112 within the annulus, the crown114 may automatically dock into the gasket member 112, e.g., ifcooperating connectors are provided on the crown 114 and gasket member112. In addition or alternatively, the pilot sutures may be used tosecure the crown 114 to the gasket member 112, e.g., by knotting andcutting the pilot sutures, similar to the embodiments described above.

Turning to FIGS. 11-13, yet another embodiment of a heart valve assembly210 is shown that includes a gasket member 212 and a crown 214. Similarto the previous embodiments, the gasket member 212 may include anannular ring 218 and a sewing cuff or ring 220, and the crown 214 mayinclude a frame 232 and a plurality of leaflets 233. Also, similar tothe previous embodiments, the annular ring 218 includes a circumferencegenerally defining a plane 216 and a longitudinal axis 217. In addition,similar to the previous embodiments, the gasket member 212 and/or crown214 may include one or more connectors for securing the crown 214relative to the gasket member 212. For example, as shown in FIGS. 13 and14, the gasket member 212 may include a clip 250 that captures orotherwise secures one or more regions of the crown 214, as describedfurther below.

In one embodiment, the annular ring 218 may have a generally circularshape generally parallel to the plane 216, as best seen in FIG. 12, andan undulating shape relative to the longitudinal axis 217 (or in and outof the plane 216), as best seen in FIGS. 11 and 13. For example, as bestseen in FIG. 13, the annular ring 218 may include a single undulation219 at a predetermined location around the circumference of the annularring 218. The undulation 219 may have rounded edges or blunt anglededges (not shown). As explained further below, the undulation 219 mayaccommodate implantation of the heart valve assembly 210 withoutsubstantial interference with the anterior leaflet of a neighboringmitral valve. Alternatively, the annular ring 218 may include multipleundulations, e.g., three undulations similar to the embodiment describedabove with reference to FIGS. 9 and 10. In addition or alternatively,the annular ring 218 may have a multi-lobular shape about thecircumference, including lobes separated by scallops or cusps (notshown), e.g., similar to the previous embodiments.

With additional reference to FIG. 13, the annular ring 218 may beexpandable and/or contractible such that the diameter (or othercross-section if the annular ring 218 is noncircular) may be adjusted,e.g., based upon the anatomy of the patient encountered during aprocedure. In one embodiment, the annular ring 218 may biased to expandto a predetermined diameter. Thus, the annular ring 218 may becontracted radially to a smaller diameter, e.g., to facilitate deliveryinto an annulus, yet may be resiliently expandable to dilate tissuesurrounding the annulus and/or to facilitate securing the gasket member212 within the annulus.

For example, as shown, the annular ring 218 may be an open bandincluding overlapping ends 226 that may slide relative to one another toaccommodate expansion and/or compression. The annular ring 218 may besized such that, in a relaxed state (free from any outside forces), theannular ring 218 may have a predetermined diameter slightly larger thanthe dilated cross-section of a tissue annulus, e.g., between aboutnineteen and thirty millimeters (19-30 mm), or between about twentythree and twenty five centimeters (23-25 cm). In the relaxed state, theends may remain overlapped at least partially, or, alternatively, theends may be spaced apart such that the annular ring 218 has a “C” shape.

In one embodiment, the overlapping ends 226 may be substantially smoothor otherwise free from any protrusions to facilitate their slidingrelationship. In addition or alternatively, the ends 226 may include oneor more cooperating elements (not shown) for limiting relative movementof the ends. For example, the cooperating elements may limit the annularring 218 to expand and/or contract within a predetermined range ofdiameters. Exemplary cooperating elements that may be provided aredisclosed in co-pending application Ser. No. 10/327,821, incorporated byreference above.

Alternatively, the annular ring may be a substantially enclosed bandthat may be resiliently compressed to a smaller diameter. For example,as shown in FIG. 13A and described further below, the annular ring 218′may be formed from a plurality of sinusoidal elements 219′ connectedend-to end about the circumference of the annular ring 218.′ The annularring 218′ may be formed as a continuous band, e.g., by laser cutting,mechanical cutting, etching, or otherwise forming a tube into theannular ring 218.′ Alternatively, the sinusoidal elements 219′ may beformed from a flat band, e.g., by laser cutting, mechanical cutting,etching, and the like, and the loose ends of the sinusoidal elements219′ may be attached to one another, e.g., by welding, interference fit,adhesives, connectors, and the like, after the band is rolled into theannular ring 218.′

The sinusoidal elements 219′ may be resiliently compressed by a radiallycompressive force, i.e., to reduce the distance between adjacentsinusoidal elements 219,′ to reduce the diameter of the annular ring218.′ This reduced diameter configuration may facilitate introduction ofthe annular ring 218′ into a biological annulus. When the force isremoved, the sinusoidal elements 219′ may resiliently expand to increasethe diameter, e.g., until the annular ring 218′ is secured within atissue annulus. Optionally, the annular ring 218′ may be sufficientlybiased to at least partially dilate the biological annulus, i.e., directtissue surrounding the biological annulus radially outwardly to maximizethe open area of the biological annulus.

Returning to FIGS. 11 and 13, as shown, the annular ring 218 has asubstantially straight or cylindrical wall, e.g., extendingsubstantially parallel to the longitudinal axis 217. A substantiallystraight wall may accommodate implantation within the tissue annulus ofthe native valve being replaced, e.g., allowing the wall of the annularring 218 to dilate and/or retain the tissue surrounding the annulusduring and after implantation of the heart valve assembly 210.Alternatively, the annular ring 218 may have a tapered shape, e.g.,being wider on its upper or lower edge (not shown). For example, if theannular ring 218 has a larger diameter about the upper edge than thelower edge to define a frusto-conical shape that may accommodateimplantation supra-annularly, i.e., at least partially above the tissueannulus. In further alternatives, the wall of the annular ring 218 mayinclude a substantially straight portion and a tapered portion, similarto the embodiments disclosed in application Ser. No. 10/327,821,incorporated by reference above.

The annular ring 218 may be formed from an elastic or superelasticmaterial, such as Nitinol, or any of the other materials describedelsewhere herein. For example, the annular ring 218 may be cut from aflat sheet of base material having a desired thickness for the annularring 218, e.g., between about 0.1-0.5 millimeters, for example, by lasercutting, mechanical cutting, and the like. Thus, the annular ring 218may be initially formed as a long band of material, having a widthcorresponding to the desired width of the annular ring 218, e.g.,between about 1.5-2.5 millimeters, and a length corresponding to adesired circumference of the annular ring 218, e.g., between about 55-90millimeters. Optionally, the undulation(s) 219 may be formed as the bandis cut out of the flat sheet. Alternatively, the undulation(s) 219 maybe formed in the band after cutting, e.g., by plastically deforming theband material and/or heat setting the undulation(s) 219 into the band.

The band may then be wrapped around a mandrel or otherwise restrained ina generally cylindrical shape with the ends 226 adjacent to one another,and the band may be heat treated or otherwise processed to program thegenerally cylindrical shape to create the annular ring 218. Thegenerally cylindrical shape may include the ends 226 overlapping oneanother, as shown in FIGS. 12 and 13, or spaced apart from one anotherto provide an open “C” shape (not shown). Optionally, a tapered shapemay also be formed in one or more portions of the annular ring 218,e.g., based upon the shape of the band cut from the base material and/orby heat treating the material once restrained in the tapered shape(which may be simultaneous or separate from heat setting the band in thegenerally cylindrical shape).

When the annular ring 218 is at least partially covered with fabric (notshown), the fabric may be wrapped around the annular ring 218, whileaccommodating expansion and contraction of the annular ring 218. Forexample, at least near the ends 226, the fabric may not be secured tothe annular ring 218, allowing the ends 226 to slide circumferentiallyrelative to the fabric. Optionally, sutures and the like (not shown) maybe used to secure the fabric to the annular ring 218 at locationsremoved from the ends 226, e.g., at an intermediate location about thecircumference of the annular ring 218. Alternatively, the entire annularring 218 may be free to slide within the fabric wrapped around theannular ring 218.

Returning to FIGS. 11 and 12, the sewing cuff 220 may be attached to orotherwise extend around the annular ring 218. The sewing cuff 220 maysimply be a layer of fabric or other material covering at least aportion of the annular ring 218. For example, a layer of fabric (notshown) may cover all of the annular ring 218 (other than any connectorsand/or bearing surfaces, if any) and/or may include a section ofmaterial extending radially outwardly from the annular ring 218, similarto the previous embodiments. Optionally, the sewing cuff 220 may includeflexible core material that may be attached to or otherwise extendaround the annular ring 218.

Turning to FIGS. 15A and 15B, exemplary embodiments of a flexible core260 are shown that include a lattice extending around a circumference ofthe core 260. As shown, the lattice includes at least two spaced apartcircumferential elements 262 and a plurality of ribs or transverseelements 264 extending between the circumferential elements 262, therebydefining openings 266 through the lattice. The openings 266 may becompletely open, i.e., free from any material. Alternatively, theopenings 266 may be recesses including a relatively thin wall of corematerial, i.e., that is substantially thinner than the circumferentialelements 262 and/or ribs 264. For example, the circumferential elements262 and/or ribs 264 may have a thickness between about 0.001-0.005 mm,while the openings 266 may have a wall thickness of not more than abouthalf that of the circumferential elements 262 and/or ribs 264. In anexemplary embodiment, the openings 266 may have a thickness not morethan about half that of the circumferential elements 262 and/or ribs264. Alternatively, the lattice may include only the circumferentialelements 262 or ribs 264 with thin wall openings extending betweenadjacent elements (not shown).

In a relaxed state (free from external forces), the core 260 may adopt agenerally planar annular shape, as shown in FIG. 15A. Alternatively, ina relaxed state, the core 260 may adopt an undulating annular shape, asshown in FIG. 15B. The core 260 may also be tapered, as shown in FIGS.15A and 15B, e.g., having a larger diameter or circumference about anupper circumferential element 262 a than about a lower circumferentialelements 262 b. The tapered shape of the core 260 may define an anglerelative to the longitudinal axis 217, e.g., between about twenty andforty five degrees (20-45°).

The material of the core 260 may be substantially flexible, e.g.,manufactured in a desired annular shape (such as those just described),yet easily deformed, e.g., deflected, stretched, and/or compressed. Thecore 260 may be sufficiently flexible to be “floppy,” i.e., such thatthe core 260 conforms easily and substantially based upon the particularanatomy and/or implantation arrangements encountered duringimplantation. Thus, when the sewing cuff 220 is placed above or within atissue annulus within a patient's heart, the core 260 may conform to thesurrounding anatomy and/or may deform when the crown 214 is secured tothe gasket member 212, e.g. to enhance sealing between the crown 214 andthe gasket member 212.

For example, when implanted within or above a tissue annulus, the core260 may lie against the surrounding tissue, thereby changing its shapefrom its original generally circular or multi-lobular shape, changingthe shape of any undulations, and/or changing the angel of the originaltaper. Thus, the core 260 may become more vertical or inward when itlies against the commissures (not shown) of the tissue annulus, andbecome more horizontal or outward when it lies within the sinuses aboveand between the commissures. When fasteners (not shown) are driventhrough the sewing cuff 220, the core 260 may resiliently stretch orcompress to distribute forces from the fasteners more evenly, which mayreduce bunching of the sewing cuff 220 or other distortions that mayotherwise result in leakage, as explained further below.

Exemplary materials for the core 260 include silicone or otherelastomeric materials, foam, fabric, felt, polymers, and the like. Inaddition or alternatively, the core 260 may include swellable material,e.g., foam or sponge materials that may expand when exposed to fluid,such as blood. The materials may be molded or otherwise formed into thecore 260, e.g., using known molding, extrusion, cutting, or othermanufacturing procedures. For example, the core 260 may be injectionmolded or otherwise formed in its annular shape. Alternatively, the core260 may be molded or otherwise formed as a flat sheet, and rolled intothe annular shape. In this alternative, the ends of the sheet may beattached to one another, e.g., using sutures, adhesives, ultrasonicwelding, and the like. Optionally, to provide a tapered shape, one ormore wedges (not shown) may be cut out of the band to provide a desiredtapered but annular shape.

Optionally, the core 260 may include one or more ears 268, which mayextend from one of the circumferential elements 262. For example, asshown, a single ear 268 extends upwardly from upper circumferentialelements 262 a. The ear(s) 268 may be provided at a predeterminedlocation about the circumference of the core 260 (and consequently, thegasket member 212), e.g., to provide a visual and/or tactile marker, asexplained further below.

In another option, portions of the core 260 may be disconnected fromother portions, e.g., to prevent puckering. For example, if the core 260is formed from a rolled sheet (not shown), ends of the sheet (also notshown) may remain loose to allow the ends to move relative to oneanother. In addition or alternatively, the circumferential elements 262may be severed, e.g., vertically, and/or individual ribs 264 may bepartially cut or otherwise separated from adjacent ribs 264. Thesefeatures may allow localized strain on elements of the core 260, whichmay prevent puckering or otherwise enhance sealing between the core 260and surrounding tissue.

Turning to FIG. 16, another embodiment of a sewing cuff 220′ is shownthat includes a core 260′ extending from an annular ring 218′ of agasket member 212.′ The core 260′ includes a base or web 261′ from whicha plurality of ribs 264′ extend. As shown, the ribs 264′ extend onlyfrom an upper surface of the base 261,′ e.g., generally upwardly. Inaddition or alternatively, ribs (not shown) may also extend from a loweror outer surface of the base 261,′ e.g., generally downwardly and/oroutwardly. The ribs 264′ may be relatively narrow, thereby enhancing theflexibility of the ribs.′

The base 261′ and ribs 264′ may be integrally formed together, e.g., asa single molded component from silicone or other materials, similar tothe previous embodiments. A lower edge of the base 261′ may be attachedto the annular ring 218,′ e.g., by chemical bonding, heat bonding,interference fit, molding, and the like. The lower edge of the base 261′may be relatively thick and/or rigid, e.g., to support the ribs 264,′while the rest of the base 261′ may be relatively thin, e.g., to provideflexibility for the base 261′ such that the base 261′ can conform to thesurrounding anatomy encountered, similar to the previous cores 260,described with reference to FIGS. 15A and 15B. As shown in FIG. 16, thebase 261′ and ribs 264′ may be covered with a fabric covering 270′ toprovide the sewing cuff 220.′ The fabric covering 270′ may also extendover the annular ring 218,′ e.g., to substantially cover all of theexposed surfaces of the gasket member 212,′ e.g., to encourage tissueingrowth. If the annular ring 218′ is expandable, the fabric covering270′ may not be connected to all or portions of the annular ring 218′ toaccommodate expansion and contraction, similar to the previousembodiments.

Optionally, as shown in FIG. 16, the ribs 264′ may include notches 265′that may define a rim or other peripheral border corresponding, forexample, to the size and/or shape of a crown (not shown) that may besecured to the gasket member 212.′ When a crown is advanced against thesewing cuff 220,′ the frame (also not shown) of the crown may engage orbe received by the notches 265.′ The ribs 264′ may be resilientlycompressed between the base 261′ and the crown, e.g., to substantiallyfill any spaces between the base 261′ and the crown, which may enhancesealing between the crown and the gasket member 212.′

Returning to FIGS. 11 and 12, the crown 214 generally includes anannular shaped body or frame 232 and one or more leaflets or other valveelements 233. With additional reference to FIG. 14, the frame 232 mayhave a noncircular, e.g., multiple lobular shape, for example, atri-lobular shape, including three lobes 240 separated by cusps orscallops 238. The frame 232 may have an undulating shape alternatingbetween adjacent lobe portions 240 and scallop portions 238, e.g., suchthat the lobe portions 240 are lower than the scallop portions 238,similar to the previous embodiments. In addition, the frame 232 mayinclude commissures 234.

As shown in FIG. 12, the frame 232 may include a plurality of struts 235(which may be single piece or laminate structures, not shown) that maybe attached to and/or otherwise carry the leaflets 233, e.g., usingsutures and the like (not shown), similar to the previous embodiments.The struts 235 may be attached to the frame 232 by spacers 237 that mayanchor an intermediate region of the struts 235 to the frame 232, whileallowing ends of the struts 235 to move to open and close the leaflets233, similar to the valves disclosed in U.S. Pat. No. 6,371,983,incorporated by reference above. The struts 235, spacers 237, and frame232 may be connected to one another, e.g., by cooperating detents, suchas tabs and mating pockets (not shown), and/or by mechanical or chemicalbonding.

Optionally, the gasket member 212 and/or crown 214 may include one ormore connectors for securing the crown 214 to the gasket member 212,similar to the previous embodiments. The gasket member 212 and/or crown214 may also include fabric coverings or other matrices, coatings,and/or guides, also similar to the previous embodiments.

For example, as best shown in FIGS. 13 and 14, the gasket member 212 mayinclude a clip 250 for securing the crown 214 relative to the gasketmember 212. The clip 250 may include a plurality of tabs or othersecuring elements 252, 254 that engage at least a portion of the crown214. For example, the clip 250 may generally define a diameter or othercross-section that is larger than the frame 232 of the crown 214. Uppertabs 252 may extend inwardly from the clip 250, e.g., at locationscorresponding to the lobes 240 of the frame 232, while lower tabs 254extend inwardly from the clip 250, e.g., at locations corresponding tothe scallops 248 of the frame 232. The upper tabs 252 may be angleddownwardly, e.g., to define angled upper surfaces.

The clip 250 may be secured to the annular ring 218 and/or sewing cuff220 of the gasket member 212 to provide a single, integral component.For example, one or more portions, e.g., regions adjacent the lower tabs254, of the clip 250 may be captured by the fabric covering (not shown)that covers the annular ring 218 and/or sewing cuff 220. In addition oralternatively, one or more sutures (not shown) may be used to tie theclip 250 to the annular ring 218 and/or sewing cuff 220. In furtheralternatives, the clip 250 may be attached to the annular ring 218and/or sewing cuff 220 by bonding with an adhesive, welding,interference fit, and the like.

With particular reference to FIG. 14, during implantation, as the frame232 of the crown 214 is advanced downwardly towards the clip 250, thelower edge of the frame 232 may contact the angled upper surfaces of theupper tabs 252. As the frame 232 is advanced further, the upper tabs 252may slide radially outwardly, because of the angled upper surfaces untilthe frame 232 clears and passes below the upper tabs 252 and contactsthe lower tabs 254. The tabs 252 may then resiliently deflect backinwardly, thereby passing above the frame 232. The frame 232 is thuscaptured between the upper and lower tabs 252, 254, thereby securing thecrown 214 relative to the gasket member 212. Alternatively, the crown214 may be angled relative to the gasket member 212 to allow a portionof the frame 232 to be received under one or more of the upper tabs 252,and then the remainder of the frame 232 may be pushed under theremaining upper tabs 252, similar to the methods described furtherbelow.

The clip 250 may be formed from an elongate wire bent or otherwiseshaped into the shape shown, whereupon its ends may be attached to oneanother, e.g., by welding, mechanical bonding, chemical bonding, matingconnectors, and the like. Alternatively, the clip 250 may be cut orotherwise formed from a flat sheet of material as an enclosed loop thatmay also be bent or otherwise shaped into the shape shown. In a furtheralternative, the clip 250 may be formed from a band of material cut froma sheet that may be shaped into the shape shown, whereupon its ends maybe attached to one another, similar to the wire. The clip 250 may beformed from an elastic or superelastic material, such as Nitinol, thatmay be heat treated to set the final shape into the clip material. Thus,the clip material may allow the upper tabs 252 of the clip 250 to deformoutwardly as the frame 232 is advanced against the clip 250, yetresiliently return inwardly to substantially securely engage the frame232. After the clip 250 has been formed, the clip 250 may be secured tothe annular ring 218 and/or sewing cuff 220 to create the gasket member212.

To make the heart valve assembly 210 of FIG. 11, the components, e.g.,the annular ring 218, frame 232, struts 235, spacers 237, and clip 250may be formed, e.g., using the methods and materials described elsewhereherein. If the sewing cuff 220 includes a core 260, the core 260 mayalso be formed, e.g., using the methods and materials described above.The annular ring 218, core 260, and clip 250 may be assembled together,as described above, e.g., using sutures and/or by wrapping one or morefabrics or other covering over and/or around exposed surfaces of theannular ring 218 and core 260, and/or around portions of the clip 250.When assembled, the core 260 may be substantially covered with fabric toprovide the sewing cuff 220, which extends radially from the annularring 218. In one embodiment, the sewing cuff 220 extends from an upperedge of the annular 218, e.g., for intra-annular placement of theannular ring 218 and supra-annular placement of the sewing cuff 220.Alternatively, the sewing cuff 220 may extend from a lower edge orintermediate region of the annular ring 218 (not shown) for otherimplantation configurations.

Returning to FIG. 11, the heart valve assembly 210 may be implantedwithin a biological annulus, similar to the previous embodiments. Withthe annular ring 218 contracted into a relatively small diameter (if theannular ring 218 is radially compressible), the gasket member 212 may beadvanced into the annulus using a delivery tool (not shown). The gasketmember 212 may be advanced until the annular ring 218 extends at leastpartially into the biological annulus. In one embodiment, the annularring 218 extends entirely through the biological annulus, with the loweredge of the annular ring 218 remaining free within the sub-annular spacebelow the biological annulus. The sewing cuff 220 may contact the tissuewithin the supra-annular space above the biological annulus, althoughthe sewing cuff 220 may not provide any structural support of theannular ring 218.

If the annular ring 218 is expandable or otherwise compressed, theannular ring 218 may then be expanded within the biological annulus,e.g., to dilate the biological annulus or otherwise direct thesurrounding tissue outwardly against the underlying tissue structures.For example, the annular ring 218 may simply be released by the deliverytool, whereupon the annular ring 218 may resiliently expand against thetissue surrounding the biological annulus, thereby substantiallysecuring the annular ring 218 (and consequently, the gasket member 212)relative to the biological annulus. In addition or alternatively, adilation tool (not shown) may be advanced into the gasket member 212 andexpanded to forcibly (e.g., plastically) expand the annular ring 218within the biological annulus. An exemplary dilation tool that may beused is shown in co-pending application Ser. No. 10/327,821,incorporated by reference above.

If the sewing cuff 220 is restrained by the delivery tool, the sewingcuff 220 may be released to allow the sewing cuff 220 to contact thesurrounding tissue, e.g., within the aortic root above the biologicalannulus. Because of the floppy (i.e., flexible and conformable) natureof the core 260, the sewing cuff 220 may adopt the shape of thesurrounding tissue, e.g., lying flatter within the coronary sinusregions, while becoming more vertical adjacent the commissures.

If the sewing cuff 220 includes an ear 268, the gasket member 212 may beangularly aligned in a predetermined manner during advancement into thebiological annulus. For example, if the sewing cuff 220 includes asingle ear 268, the ear 268 may be aligned with the commissure betweenthe right coronary and non-coronary sinus cusps (the RC/NC commissure).Consequently, the ear 268 may provide a visual and/or tactile marker forthe surgeon, identifying the location of underlying nerves in the RC/NCcommissure region. In addition or alternatively, if the annular ring 218includes an undulation 219, the gasket member 212 may be angularlyaligned to position the undulation 219 above the commissure between theleft coronary sinus and non-coronary sinus cusps (the LC/NC commissure).The undulation 219 may thereby provide clearance for the anterior mitralleaflet to avoid interference with the mitral valve. If the gasketmember 212 includes both the ear 268 and the undulation 219, the ear 268and undulation 219 should be angularly aligned relative to one anothersuch that the ear 268 is aligned with the RC/NC commissure when theundulation 219 is aligned with the LC/NC commissure.

With the gasket member 212 in place, a plurality of fasteners, e.g.,clips, staples, sutures, and the like, may be directed through thesewing cuff 220 into the tissue surrounding the biological annulus tosecure the gasket member 112 relative to the biological annulus. If thesewing cuff 220 includes ribs (not shown) on a lower surface of a core260, the ribs may be compressed at least partially between the sewingcuff 220 and the surrounding tissue to enhance sealing. Optionally, thecore 260 may swell when exposed to fluid to enhance sealing of thesewing cuff 220. In addition or alternatively, material may be injectedinto the sewing cuff 260, e.g., using a syringe and the like (notshown), or otherwise applied to an exterior or interior of the sewingcuff 260, e.g., to fill any gaps or puckers that may result after thefasteners are delivered. Exemplary materials that may be injectedinclude silicone or other polymers, which may expand upon delivery toenhance sealing.

The crown 214 may then be advanced into the biological annulus, e.g.using another delivery tool or the same tool (not shown) used to deliverthe gasket member 212, and angularly aligned with the gasket member 212.As the crown 214 is advanced towards the gasket member 212, the frame232 of the crown 214 may engage the clip 250, as described above,thereby securing the crown 214 to the gasket member 212. If the sewingcuff 220 includes ribs (not shown) on the core 260 that extend upwardly,the ribs may be compressed between the frame 260 and the sewing cuff 220to also enhance sealing. Any tools may be removed, and the procedurecompleted using known methods, similar to the previous embodiments.Optionally, the crown 214 may include a flexible skirt 242 that mayenhance sealing with the sewing cuff 220. The flexible skirt 242 mayinclude a core (not shown), similar to the sewing cuff 220 describedabove. In addition or alternatively, additional sealing material may beinjected or otherwise applied to the skirt 242 to enhance sealing.

Turning to FIGS. 17A-19, yet another embodiment of a heart valveassembly 310 is shown that includes a gasket member 312 and a crown 314,which may be at least partially covered by one or more pieces of fabricor other material 336, 370 (not shown in some drawings for clarity),similar to other embodiments described herein. Generally, the gasketmember 312 includes an annular ring 318, a flexible baleen element 330,and a sewing cuff or ring 320, and the crown 314 includes a frame 332,and a plurality of leaflets 333 carried by struts 335. The annular ring318 and/or crown 314 generally include a circumference or otherperiphery extending generally parallel to a plane 316 and transverse toa longitudinal axis 317.

Similar to the previous embodiments, the gasket member 312 and/or crown314 may include one or more connectors for securing the crown 314relative to the gasket member 312. For example, as shown in FIG. 17B,the gasket member 312 may include a clip 350 that captures or otherwisesecures one or more regions of the crown 314, e.g., between tabs 352,354, similar to the previous embodiments. In addition or alternatively,one or more other connectors (not shown), such as the other embodimentsdescribed elsewhere herein, may be provided for securing the crown 314to the gasket member 312.

In one embodiment, the annular ring 318 may have a substantiallycircular shape generally parallel to the plane 316, as best seen in FIG.18. In addition, the annular ring 318 may have an undulating shaperelative to the longitudinal axis 317. For example, an upper edge 319 aof the annular ring 318 may include one or more undulations, e.g., threeundulations corresponding to the tri-lobular shape of the sinus cavityor supra-annular space above a biological annulus. In addition oralternatively, a lower edge 319 b may include at least one undulation(not shown), e.g., corresponding to a location of the anterior leafletof a neighboring mitral valve, similar to the previous embodiments. In afurther alternative, the annular ring 318 may have a multi-lobular shapeabout the circumference, e.g., including lobes separated by scallops orcusps (not shown), similar to the previous embodiments.

With additional reference to FIG. 18, the annular ring 318 may includeoverlapping edges 318 a that are secured to one another, e.g., byresistance welding, ultrasonic welding, adhesives, fasteners, and thelike. Alternatively, the overlapping edges 318 a may be movable relativeto one another (not shown), e.g., allowing the annular ring 318 toexpand and/or contract such that the diameter (or other cross-section ifthe annular ring 218 is noncircular) may be adjusted, similar to theprevious embodiments. In another alternative, the annular ring 318 maybe a substantially enclosed band that may be resiliently compressed to asmaller diameter, e.g., formed from a plurality of sinusoidal elements(not shown) connected end-to end about the circumference of the annularring, similar to the annular ring 218′ shown in FIG. 13A and describedelsewhere herein.

The annular ring 318 may have a substantially straight or cylindricalwall, e.g., extending substantially parallel to the longitudinal axis317, as shown. Alternatively, at least a portion of the annular ring 318may have a tapered shape, e.g., being wider on its upper or lower edge(not shown), similar to other embodiments described herein. The annularring 318 may be formed from elastic or superelastic material, such asNitinol, and/or using any of the other materials and methods describedelsewhere herein.

As best seen in FIG. 18, the sewing cuff 320 may include a flexible core360, e.g., including a lattice extending around a circumference of theflexible core 360. As shown, the flexible core 360 includes an uppercircumferential element 362 and a plurality of ribs or transverseelements 364 extending generally vertically from the circumferentialelement 362, thereby defining openings 366. The openings 366 may berecesses including a relatively thin wall of core material, i.e., thatis substantially thinner than the circumferential element 362 and/orribs 364, similar to the previous embodiments. Alternatively, theopenings 366 may be completely open, i.e., extending completely throughthe flexible core 360 such that the openings 366 are free from anymaterial. In addition or alternatively, the flexible core 360 mayinclude a lower circumferential element (not shown), e.g., similar tothe embodiment shown in FIG. 15A.

Optionally, the flexible core 360 may also include one or more ears 368(one shown), which may extend from the upper circumferential element362.

In a relaxed state, the core 360 may be tapered, e.g., having a largerdiameter or circumference about the upper circumferential element 262than about its lower edge 367. The core 360 may adopt an undulatingannular shape, e.g., including three undulations, or may have agenerally planar shape. The material of the core 360, e.g., silicone orother elastomeric materials, foam, felt, polymers, and the like, may besubstantially flexible, yet may be easily deformed, e.g., deflected,stretched, and/or compressed. Thus, when the sewing cuff 320 is placedabove or within a tissue annulus within a patient's heart, the core 360may conform at least partially to the surrounding anatomy and/or maydeform when the crown 314 is secured to the gasket member 312, e.g. toenhance sealing between the crown 314 and the gasket member 312.Optionally, the core 360 may be attached to the annular ring 318, e.g.,along the upper edge 319 a. For example, the core 360 may be fused alongthe upper edge 319 a, e.g., by softening or melting the core material,or attached using adhesives, an interference fit, one or more fasteners(not shown), and the like. Alternatively, the core 360 may be buttedagainst the annular ring 318 or otherwise disposed adjacent the upperedge 319 a, and held in relative position by the fabric covering 370,one or more sutures or other fasteners (not shown), and the like.

With continued reference to FIGS. 17A-19, the baleen element 330 may bean annular member including a plurality of flexible fingers 382extending from a base 380. The base 380 may have a diametercorresponding substantially to the annular ring 318, e.g., such that thebase 380 may be disposed around the annular ring 318. Optionally, thebase 380 may be secured to the annular ring 318, e.g., by one or more ofan interference fit, adhesive, ultrasonic welding, one or morefasteners, and the like. The fingers 382 may be biased to extendoutwardly from the base 380, thereby defining a frusto-conical shape, asshown in FIG. 18. For example, the baleen element 330 may be biased toan angle of between about one and ten degrees (1-10°) relative to thelongitudinal axis 317.

The baleen element 330 may be formed from an elongate flat band havingthe fingers 382 formed therein, such as the baleen elements 330 shown inFIGS. 20A-20D. In FIGS. 20A and 20B, the fingers 382, 382′ havesubstantially uniform lengths, while in FIGS. 20C and 20D, the fingers382″, 382′″ have varying lengths, e.g., defining undulations or lobes,which may correspond to a shape below a biological annulus within whichthe gasket member 318 may be implanted. In addition, the fingers 382,′382″ in FIGS. 20B and 20C are thicker than the fingers 382, 382′″ inFIGS. 20A and 20D, which may provide a greater outward bias to enhancebillowing the fabric covering 336 outwardly.

The baleen element 330 may be formed from a relatively thin band ofmylar, polyester, or other polymer, an elastic or superelastic alloy,such as Nitinol, and the like, from which the base 380 and fingers 382may be cut, e.g., by die-cutting, laser-cutting, and the like. Inexemplary embodiments, the band (and consequently, the baleen element330) may have a thickness between about 0.002 and 0.010 inch (0.05-0.25mm). After the baleen element 330 is formed, the base 380 may have awidth, e.g., between about 0.01-0.08 inch (0.25-2.0 mm), and the fingers382 may have lengths, e.g., between about 0.01-0.08 inch (0.25-2.0 mm),and widths between about 0.01-0.04 inch (0.25-1.0 mm). The flat band maydefine a curve, e.g., such that when the band is rolled and its endsattached together, the base 380 and/or fingers 382 may be tapered todefine a frusto-conical shape, as described above. The ends of the bandmay be attached together by ultrasonic welding, adhesives, and the like.Alternatively, the baleen element 330 may be molded or otherwise formedas a continuous piece in the frusto-conical shape.

Turning to FIG. 19, a fabric covering 336 may be provided around theannular ring 318 and the baleen element 330, and a fabric covering 370may be provided around the flexible core 360. As shown, the fabriccovering 336, 370 may be a single piece of fabric that may be wrappedaround the components of the gasket member 312, with any loose ends oredges 371 of the fabric secured together, e.g., by sutures 372, and/orby adhesives, other connectors (not shown), and the like. Alternatively,multiple pieces of fabric may be used, if desired. Optionally, thefabric covering 336, 370 may be fixed relative to one or more locationsof the components of the gasket member 312 (e.g., the annular member318, the flexible core 360, and/or the baleen element 330), e.g., by oneor more sutures delivered through the fabric covering 336, 370 and/orone or more openings in the components.

Because the fingers 382 of the baleen element 330 are biased orotherwise flared outwardly, the fingers 382 may direct the fabriccovering 336 radially outwardly away from the annular ring 318, e.g.,adjacent the lower edge 319 b. Thereafter, the fabric covering 336 andfingers 382 may be compressed inwardly, e.g., towards or against theannular ring 318. When such compressive force is released, however, thefingers 382 may resiliently return outwardly, thereby directing thefabric covering 336 outwardly. This feature may enhance a seal betweenthe fabric covering 336 and surrounding tissue, as explained furtherbelow.

Turning to FIGS. 21A-21C, the gasket member 312 may be implanted withina biological annulus 190, e.g., to receive the crown 314 (not shown, seeFIG. 17A) and thereby provide a heart valve prosthesis 310, similar tothe previous embodiments. With the annular ring 318 and baleen element330 contracted into a relatively smaller diameter (if the annular ring318 is radially compressible), the gasket member 312 may be advancedinto the annulus 190 using a delivery tool 410. The annular ring 318 maybe advanced into the biological annulus 190 such that the sewing cuff320 is disposed within the sinus cavity or other supra-annular space192. A plurality of fasteners, such as clips 199, sutures, and the like(not shown) may be delivered through the sewing cuff 320 into the tissue194 surrounding the sinus cavity 192. Exemplary tools and methods fordelivering such fasteners are disclosed in co-pending application Ser.Nos. 10/681,700 and 11/004,445, filed Dec. 3, 2004, the entiredisclosures of which are expressly incorporated by reference herein.

With continued reference to FIGS. 21A-21C, an expandable/contractabledelivery tool 410 is shown that may be used for delivering the gasketmember 312. As shown, the delivery tool 410 includes an elongate shaft412 including a proximal handle 414 and a plurality of struts 416. Thestruts 416 may be movable between an expandable configuration (shown inFIGS. 21A and 21B) and a collapsed configuration (shown in FIG. 21C),using an actuator (not shown) on the proximal handle 412. Optionally,the struts 416 may be substantially transparent members that may bemovable from a first transverse position (in the expandable position) toa second substantially axial position (in the collapsedconfiguration).Thus, the struts 416 may assume a shape similar to thestruts of an umbrella that may be selectively opened and closed.

Initially, the struts 416 of the tool 410 may be expanded, and thegasket member 312 may be secured to the struts 416, e.g., by compressingthe annular ring 318 (if compressible), and/or the baleen element 330and fabric covering 336 towards the annular ring 318 between the struts416. In this configuration, the struts 416 may substantially minimize across-section of the gasket member 312 below the sewing cuff 320, i.e.,the size of the annular ring 318 and fabric covering 336, which mayfacilitate insertion of the gasket member 312 into the biologicalannulus 190. The gasket member 312 may be releasably secured to the tool410 simply by friction or interference fit between the struts 416 andthe gasket member 312. Alternatively, the struts 416 and/or gasketmember 312 may include interlocking elements (not shown) for releasablysecuring the gasket member 312 to the struts 416.

As shown in FIG. 21 A, the gasket member 312 may be advanced into thepatient's body until the annular ring 318 extends at least partiallyinto the biological annulus 190, similar to the previous embodiments. Inone embodiment, the annular ring 218 may extend entirely through thebiological annulus, with the lower edge 319 b of the annular ring 318extending into the sub-annular space 196 below the biological annulus190. The sewing cuff 320 may contact the tissue 194 within the sinuscavity or supra-annular space 192 above the biological annulus 190. Thesewing cuff 320 and/or annular ring 318 may substantially engage thesurrounding tissue, such that, when the tool 410 is advanced furtherdistally, the gasket member 312 may be released from the struts 416, asshown in FIG. 21B. Optionally, if the struts 416 and/or gasket member312 include interlocking elements, the struts 416 may be expandedfurther to disengage the interlocking elements and/or otherwise releasethe gasket member 312. Finally, as shown in FIG. 21C, the struts 416 maybe collapsed, and the tool 410 withdrawn from the biological annulus 190and the patient's body.

When the gasket member 312 is released, the annular ring 318 mayresiliently expand within the biological annulus 190, e.g., to dilate orotherwise open the biological annulus 190. In addition, as shown inFIGS. 21B and 21C, the baleen element 330 may resiliently expandoutwardly, thereby directing the fabric covering 336 outwardly againsttissue surrounding the sub-annular space 196. The baleen element 330 maycause the fabric covering 336 to billow outwardly to enhance a sealbetween the gasket member 312 and the surrounding tissue. Because of therelatively thin, flexible nature of the baleen element 330, the gasketmember 312 may be removed, if desired, and the baleen element 330 maycreate minimal resistance. Thus, the baleen element 330 may not enhanceanchoring the gasket member 312 relative to the biological annulus 190,but, instead, may enhance billowing or other shaping of the fabriccovering 336, which may enhance apposition and/or sealing against thesurrounding tissue.

Optionally, a dilation tool (not shown) may be advanced into the gasketmember 312 after removing the tool 410, and expanded to forcibly expandthe annular ring 318 within the biological annulus, if desired, similarto the previous embodiments. If the sewing cuff 320 is restrained by thedelivery tool, the sewing cuff 320 may be released to allow the sewingcuff 320 to contact the surrounding tissue, e.g., before or whilereleasing the annular ring 318. Because of the flexible and/orconformable nature of the core 360, the sewing cuff 320 may at leastpartially conform or even substantially adopt the shape of thesurrounding tissue 194. If the sewing cuff 320 includes an ear 368, thegasket member 312 may be angularly aligned in a predetermined mannerduring advancement into the biological annulus 190, i.e., before thegasket member 312 is released from the tool 410.

With the annular member 318 and sewing cuff 330 in place, a plurality offasteners 199 may be directed through the sewing cuff 320 into thesurrounding tissue 194 to secure the gasket member 112 relative to thebiological annulus 190. The fasteners 199 may be delivered before thegasket member 312 is released from the tool 410, e.g., thereby anchoringthe gasket member 312, which may facilitate releasing the gasket member312 from the struts 416. Alternatively, the fasteners 199 may bedelivered once the gasket member 312 is released and/or after the tool410 is removed from the patient's body.

With additional reference to FIGS. 17A and 17B, the crown 314 may thenbe advanced into the sinus cavity 192, e.g. using another delivery toolor the same tool used to deliver the gasket member 312 (not shown).Optionally, the crown 314 may be angularly aligned with the gasketmember 312, e.g., with the aid of one or more markers. For example, asshown in FIG. 17A, the gasket member 312 may include commissure markers322 a and/or nadir markers 322 b, e.g., one or more sutures or otherstitches, ink or dye indicators, and the like, that may be provided ondesired locations of the sewing cuff 320 to facilitate orienting thegasket member 312 during insertion. The crown 314 may also includemarkers 334, e.g., on a flexible skirt 342 extending radially outwardlyfrom the crown 314. As shown, the markers 334 may be located on thenadir of the crown 314, such that the markers 334 may be aligned withthe nadir markers 322 b on the gasket member 312 to angularly orient thecrown 314 before being secured to the gasket member 312.

If the gasket member 312 includes the clip 350, the crown 314 may beadvanced towards the gasket member 312, and tilted such that the frame332 of the crown 314 may be received under two of the tabs 352 of theclip 350. The crown 314 may then be forced down into a planarorientation, causing the final tab 352 to be deflected outwardly untilthe frame 332 passes under the final tab 352. Alternatively, a tool,such as a hemostat, a suture line, or specialized valve holder (notshown) may be used to deflect the final tab 352 sufficiently such thatthe frame 332 may be received thereunder, thereby securing the frame tothe clip 350.

In alternative embodiments, other materials and/or methods may be usedfor securing the crown 314 to the gasket member 312, such as thosedescribed elsewhere herein. For example, one or more clips or otherfasteners (not shown) may be directed through the crown 314 and thesewing cuff 320 into surrounding tissue, as described above. Forexample, if the crown 314 includes a flexible skirt 342, the fastenersmay be directed through the skirt 342 and the sewing cuff 320substantially simultaneously. The fasteners may be spaced about thecircumference of the crown 314, for example, e.g., at locations adjacentthe nadir markers 334, thereby securing the crown 314 and/or enhancing aseal between the crown 314 and the sewing cuff 320.

Alternatively or in addition, one or more magnets (not shown) may beprovided on the crown 314 and gasket member 312 (e.g., on the sewingcuff 320), similar to those disclosed in application Ser. No. 327,821,incorporated by reference above. The magnets may bias the crown 314 intoa desired orientation relative to the gasket member 312, e.g., byarranging the polarity of the magnets about the circumference of thecrown 314 and gasket member 312. For example, as shown in FIG. 17C, thecrown member 314 may include a magnet 356 at each lobe 329 and cusp 328,e.g., providing six magnets 356 substantially evenly distributed aboutthe circumference of a tri-lobular crown 314. The polarity of themagnets 356 at the lobes 329 may be reversed (e.g., negative) comparedto the magnets 356 at the cusps 328 (e.g., positive). Thus, thepolarities of the magnets 356 may alternate between positive andnegative about the circumference of the crown member 314.

Similarly, the gasket member 312 may include magnets 358, e.g.,substantially evenly disposed about the circumference of the sewing cuff320. The magnets 358 may be disposed at locations corresponding to thedesired orientation of the crown member 314 relative to the gasketmember 312, e.g., at regions corresponding to the commissures and nadirsof the sinus cavity (not shown) into which the gasket member 312 is tobe implanted. The polarities of the magnets 358 on the gasket member 312may be alternated, similar to the magnets on the crown 314, therebybiasing the crown 314 to a predetermined angular orientation relative tothe gasket member 312. For example, the magnets 358 adjacent markers 322a may be oriented with a negative polarity and the magnets 358 adjacentmarkers 322 b may be oriented with a negative polarity. In thisconfiguration, the magnets 356 on the crown member 314 may be attractedto the magnets 358 on the gasket member 312 with the opposite polarity,thereby automatically orienting the crown member 314 such that the lobes329 overly the markers 322 a and the cusps 328 overly the markers 322 b.Other configurations and/or arrangements of magnets may be provided,e.g., such that the crown member 314 is automatically secured to thegasket member 312 in a desired angular orientation, e.g., to orient thecrown member 314 within the sinus cavity in a desired orientation.

Turning to FIGS. 22 and 23, in another embodiment, a heart valveassembly 510 is shown that includes a plurality of retainer elements 550that may be used to secure a crown 514 to a gasket member 512. The crown514 and gasket member 512 may include any of the embodiments describedelsewhere herein, except that the gasket member 512 includes a pluralityof retainer elements 550 that are shown more particularly in FIGS.24A-25B.

Turning to FIG. 24A, each retainer element 550 includes an enlarged base552, and a tubular section 554 extending from the base 554. The tubularsection 554 may include a plurality of slots 556 formed therein,allowing the tubular section 554 to buckle in a desired manner. In oneembodiment shown in FIG. 25A, the slots 556 may be laser-cut, orotherwise cut in a vertical pattern extending around the tubular section554. Alternatively, as shown in FIG. 25B, the slots 556′ may be cut in adiagonal pattern extending around the tubular section 554.′

An actuator 560 may be provided for causing each retainer element 550 tobuckle in a desired manner at the slots 556. For example, a pull wire562 may be provided in each tubular section 554 that is attached to thebase 552 or otherwise below the slots 556. A hypotube or other element564 having substantial column strength may be provided around oradjacent the pull wire 562. The hypotube 564 may include a distal end566 that may engage the tubular section 554 such that the base 552 maybe moved while the tubular section 554 above the slots 556 may remainsubstantially stationary.

Returning to FIGS. 22 and 23, the retainer elements 550 may be securedto the gasket member 512, e.g., to a sewing cuff 520 extending radiallyfrom an annular member 518. For example, the enlarged bases 552 may beembedded within the sewing cuff 520 such that the tubular sections 554extend through the sewing cuff 520. Alternatively, the bases 552 may besecured to an outer surface of the sewing cuff 520, e.g., using one ormore sutures or other fasteners, adhesives, ultrasonic welding, and thelike.

Each of the actuators 560 may extend upwardly from the gasket member512, terminating in a handle 568 on the pull wire 562 that extendsbeyond the hypotube 564, best seen in FIG. 23. As shown in FIG. 22, thecrown 514 may include a plurality of receiver elements 538, e.g.,openings or tubular elements secured to the skirt 542, frame, or fabriccovering. Exemplary receiver elements 538 that may be provided on thecrown 514 are disclosed in application Ser. No. 10/765,725, incorporatedby reference above. The receiver elements 538 may receive the actuators560 therethrough, such that the crown 514 may be advanced down theactuators 560 until disposed against or adjacent the gasket member 512,e.g., in a desired angular orientation.

With the crown 514 disposed against the gasket member 512 (e.g., asshown in FIG. 24C), the actuators 560 may be activated to expand theretainer elements 550 to secure the crown 514 to the gasket member 512.Returning to FIGS. 24A and 24B, the pull wires 562 may be pulled usingthe handles 568 while the hypotubes 564 restrain the tubular sections554 of the retainer elements 550 from moving. This compressive forcecauses the tubular sections 554 to buckle at the slots 556, therebycapturing the receiver elements 538 between the buckled tubular sections554 and the enlarged bases 552, as shown in FIG. 24C. The pull wires 562may include a weakened joint (not shown) adjacent the enlarged bases 552such that additional force on the pull wires 562 causes the weakenedjoints to break, thereby allowing the pull wires 562 and hypotubes 564to be removed from the patient's body, leaving the crown 514 secured tothe gasket member 512.

Turning to FIGS. 26A-28C, yet another embodiment of a connector 650 isshown that may be used to secure a crown or other valve member 614 to agasket member 612. As shown, the connector 650 may be a two-positionlatch 652 including a hook 654 thereon. As shown in FIGS. 26A and 26B,the latch 652 may be a substantially flat clip including two prongs 656,the ends of which may be overlapped and attached to one another, e.g.,by spot welding, riveting, bonding with adhesives, and the like, asshown in FIGS. 27A and 27B. A hook 654 or other catch mechanism may beprovided on one end, e.g., adjacent the overlapped ends.

Turning to FIGS. 28A-28C, the resulting latch 652 may be biased to movebetween an open position (shown in FIGS. 28A and 28B) and a closedposition (shown in FIG. 28C), similar to a spring hairclip. A pluralityof latches 652 (only one shown) may be attached about a circumference ofgasket member 612, which may be similar to any of the embodimentsdescribed herein, such that the hooks 654 extend above a plane definedgenerally by the gasket member 612. A crown 614, which may be any of theembodiments described herein, may be directed against the gasket member612, as shown in FIG. 28B, whereupon the latches 652 may be moved to theclosed position, as shown in FIG. 28C, thereby securing the crown 614beneath the hooks 654.

Turning to FIG. 29A, yet another alternative embodiment of a heart valveassembly 710 is shown that includes a gasket member 712 and crown 714,which may be similar to any of the embodiments described herein. Asshown, the crown 714 may include a plurality of protrusions 750extending radially outwardly from a frame 732 of the crown 714. Thegasket member 712 may include a wire mesh or other lattice 752 on aninterior surface of the gasket member 712. When the crown 714 isinserted into the gasket member 712 and rotated within a plane generallydefined by the gasket member 712, the protrusions 750 may interlock withthe mesh 752 to secure the crown 714 relative to the gasket member 714.For example, if the mesh 752 includes a plurality of interwoven diagonalthreads, wires, or other filaments, rotation of the crown 714 with theprotrusions 750 interlocked with the mesh 752 may cause the mesh tocontract radially and/or shorten vertically, thereby tightening the mesh752 around the crown 714. Thus, the mesh 752 may create a substantialinterference fit around the crown 714 that may enhance securing thecrown 714 relative to the gasket member 712.

Alternatively, as shown in FIG. 29B, the gasket member 712′ may includean annular groove 754′ along an interior surface thereof. The crown 714′may include one or more protrusions 750′ that may be received in thegroove 754′ to secure the crown 714′ to the gasket member 712.′ Forexample, the protrusion(s) 750′ may include ramped edges (not shown),allowing the protrusion(s) 750′ to be directed into the groove 754′ byrotating the crown 714′ relative to the gasket member 712.′ This actionmay direct a portion of the gasket member 712′ radially outwardlysufficiently to allow the protrusion(s) 750′ to enter and be capturedwithin the groove 754.′

Alternatively, other interlocking rings, e.g., including one or moreannular protrusions and/or grooves (not shown) may be provided thatfacilitate securing a crown to a gasket member. Optionally, suchinterlocking rings may be at least partially covered with fabric toallow tissue ingrowth and/or may be sprayed or otherwise coated with amatrix that enhances tissue ingrowth. In another option, theinterlocking rings or the protrusion(s) and/or groove(s) may be formedfrom different color materials that together change color in appearancewhen properly interlocked. The interlocking rings may be substantiallypermanently or removably attached to the crown and/or gasket member,e.g., using welding, adhesives, sutures and/or other connectors.

Turning to FIGS. 30A and 20B, still another embodiment of a heart valveassembly 810 is shown that includes a gasket member 812 and a valvemember 814, which may be similar to any of the other embodimentsdescribed herein. In this embodiment, the gasket member 812 includes oneor more latches 850, preferably a plurality of latches (not shown)disposed around the circumference of the gasket member 812. Thelatch(es) 850 may be covered with fabric 836 or other matrix allowingtissue ingrowth. The valve member 814 includes a frame 832 that is alsoat least partially covered by fabric 835. As shown, the frame 832 is notcovered with fabric at the location(s) corresponding to the latch(es)850, thereby facilitating interlocking of the latch(es) 850 with theframe 832.

As shown in FIG. 30B, the latch(es) 850 may include a hook 854 or otherelement for interlocking with the frame 832 of the valve member 814. Thelatch(es) 850 may include ramped or tapered upper end(s) (not shown),allowing the frame 832 to deflect the latch(es) 850 at least partiallyoutwardly as the frame 832 is directed towards the gasket member 812.Once the frame 832 passes below the hook(s) 854, the latch(es) 850 mayresiliently return inwardly, thereby securing the frame 832 relative tothe gasket member 812.

Turning to FIGS. 31A-32B, yet another embodiment of a latch 950 is shownthat may be used to secure a valve member 914 to a gasket member 912,such as that shown in FIGS. 33 and 34. Generally, the latch 950 includesa wire frame 952 to which a latch member 954 is pivotally attached. Thelatch member 954 includes a hook or other latch element 956 on an upperend, and a pair of ramped tabs 958 on a lower end thereof. The latchmember 954 is pivotable between a transverse or open position, shown inFIGS. 31A and 31B, and a vertical or closed position, shown in FIGS. 32Aand 322B.

In the open position, the ramped tabs 958 may be disposed in front ofthe wire frame 952, as shown in FIGS. 31A and 31B, such that the latchmember 954 is free to pivot relative to the wire frame 952. If the latchmember 954 is directed towards the vertical position, the tabs 958 maycontact the wire frame 952, thereby resisting moving the latch member954 further vertically. If additional force is applied, the ramped edgesof the tabs 958 may cause the wire frame 952 to deflect outwardly,thereby allowing the tabs 958 to pass behind the wire frame 952, asshown in FIGS. 32A and 32B. Once the tabs 958 are disposed behind thewire frame 952, the wire frame 952 may resiliently return inwardly toengage the latch member 954. Optionally, the latch member 954 mayinclude a groove 959 (shown in FIG. 31B) in one or both sides forreceiving the wire frame 952 therein, thereby substantially locking thelatch member 9544 in the closed position. The rigidity of the wire frame952 may be selected to provide sufficient softness to allow the tabs 958to pass behind the wire frame 952 with relative ease, yet the wire frame952 may be sufficiently resilient to return inwardly to secure the latchmember 954 in the closed position.

Turning to FIG. 33, a gasket member 912 is shown, which may be similarto any of the embodiments described herein. As shown, the gasket member912 includes a wire frame 952 that extends around a circumference of thegasket member 912, and to which are pivotably attached a plurality oflatch member 954, thereby providing latches 950. Although three latches950 are shown for exemplary purposes, it will be appreciated that moreor fewer latches 950 may be provided, as desired. The wire frame 952 maybe secured to the gasket member 912 by a fabric covering (not shown),similar to previous embodiments, and/or by one or more sutures or otherconnectors (also not shown). Although a single wire frame 952 is shown,it will be appreciated that a plurality of wire frames (not shown) maybe provided instead, e.g., corresponding to one or more individuallatches.

Turning to FIG. 34, the latches 950 may be used to secure a valve member914, which may be similar to any of the embodiments described herein, tothe gasket member 912 of FIG. 33. With the latches 950 in the openposition, the valve member 914 may be advanced towards the gasket member912. Once the valve member 914 is disposed below the edges of thelatches 950, the latches 950 may be activated, thereby capturing aportion of the valve member 914 (e.g., the frame) below the hooks 956.

To activate the latches 950, an actuator 960 may be provided that iscoupled to each of the latches 950 (only two shown in FIG. 34 forclarity). As shown, the actuator 960 includes a wire 962 coupled to thelatch member 954, e.g., to the hook 956. The wire 962 may be detachablyconnected to thee latch member 954, e.g., by a weakened region (notshown) that may break when a predetermined tensile force is applied tothe wire 962. Thus, a first tensile force may be applied to the wires962 to move the latches 950 from the open to the closed positions, andthen, a second greater tensile force may be applied to break the wires962 at the weakened region, whereupon the wires 962 may be removed.

Alternatively, the wire 962 may include two ends, one of which is loopedthrough an opening in the latch member 954 (not shown). To activate eachlatch 950, both ends of the wire 962 may be grasped and pulled, therebypulling the latch member 954 to the closed position. After the wire 962is used to activate the latch 950, one end may be released and pulledthrough the opening in the latch member 954 to release and remove thewire 962. In yet a further alternative, the lower end of the latches 950may be configured such that the valve member 914 contacts the lower endsdirectly, thereby directing the latches 950 to the closed position asthe valve member 914 is directed against the gasket member 912.

Turning to FIGS. 35A and 35B, still another embodiment of a latch 1050is shown that may be used to secure a valve member 1014 to a gasketmember 1012, as shown in FIGS. 36A-36C. Generally, the latch 1050includes a deformable latch element 1052 secured to the gasket member1012, which may be similar to any of the embodiments described herein,at an intermediate region of the latch element, e.g., by a suture 1054or other connector (not shown). The latch element 1052 includes opposingends 1056 that may be deformed about the intermediate region from asubstantially planar or closed position, shown in FIGS. 35B and 36C, anda bent or open position, shown in FIGS. 35A and 36A.

In the embodiment shown, the latch element 1052 includes an elongaterod, tube, or other wire, e.g., formed from Nitinol or other elastic orsuperelastic material, having enlarged balls on the ends 1056, therebyproviding a latch element similar to a “dog bone” or “cuff-link.” Thewire may be bent about an intermediate region, e.g., by pulling the ends1056 upwardly away from the gasket member 10012. When the ends 1056 arereleased, the latch element 1052 may substantially straighten towardsthe closed position shown in FIGS. 35B and 36C. In one embodiment, thelatch element 1052 may be formed from a plurality of sections of wireswith ends connected by ball welds, which may reduce the strainexperienced by each section of wire as compared to using a single lengthof wire for the latch element 1052.

In another embodiment, shown in FIGS. 37A and 37B, the latch 1050′ mayinclude a loop latch element 1052′ secured by a suture 1054.′ The latchelement 1052,′ which may include an elastic or superelastic material,e.g., Nitinol, may be formed from a wire that is looped and whose endsare attached together, e.g., by welding, interference fit, mechanicalconnectors, bonding with adhesives, and the like, to provide a bow-tieshape. Alternatively, the latch element 1052′ may be formed by cutting athin section off of a length of tubing to provide a ring having adiameter similar to the size of the loop. The ring may be deformed intothe bow-tie shape and heat set, or otherwise treated to set the bow-tieshape, yet allow the latch element 1052′ to bend. In anotheralternative, the latch element 1052′ may be laser cut from a flat sheet,a ring, or a length of tubing, and formed and treated to provide thelatch element 1052.′ Similar to the latch 1050, the latch 1050′ may bebent from a closed position, shown in FIG. 37B, to an open position,shown in FIG. 37A, by pulling upwardly on opposing ends 1056′ of thelatch member 1052.′

The latch element 1052 may be biased to the closed position, but may beresiliently deformed and retained in the open position, e.g., by aretaining element 1060. As shown in FIGS. 35A and 35A, the retainingelement 1060 may be a tubular member, e.g., a section of substantiallyrigid hypotube, having a lumen 1062 for receiving the latch element 1052therein in the open position. Because the latch element 1052 may bebiased to return to the planar position, the ends 1056 of the latchelement 1052 may bear against the inner wall of the retaining member1060. As the retaining member 1060 is removed, as shown in FIG. 35B, theends 1056 of the latch element 1052 may slide along the retaining member1060 until released, whereupon the ends 1056 may return to the closedposition.

Turning to FIGS. 36A-36C, during use, the gasket member 1012 may beintroduced into and secured to the biological annulus (not shown),similar to the previous embodiments, with the retaining member(s) 1060retaining the latch(es) 1050 in the open position. A valve member 1014,which may be similar to any of the embodiments described herein, mayinclude a receiving element 1038 through which each retaining member1060 may pass as the valve member 1014 is directed towards the gasketmember 1012, as shown in FIG. 36B. Once the valve member 1014 isdisposed adjacent the gasket member 1012, as shown in FIG. 36C, theretaining member 1060 may be withdrawn, releasing the latch 1050. Thelatch element 1052 may press downwardly on the valve member 1014,substantially securing the valve member 1014 to the gasket member 1012.

Turning to FIGS. 38A-39B, another spring latch 1150′ is shown that maybe used to secure a valve member 1114 to a gasket member 1112, which mayinclude any of the embodiments described herein. Similar to the previousembodiment, the latch 1150 may be movable between a closed position,shown in FIG. 38B, and an open position, shown in FIG. 38A, and aretaining member 1160 may be provided that may constrain the latch 1150in the open position. Unlike the previous embodiment, the latch 1150includes a post 1152 and a loop 1154 that overlies and/or surrounds thepost 1152 in the closed position, as best seen in FIG. 38B. The loop1154 may be a length of wire formed into a loop whose loose ends aresecured to the gasket member 1112. The wire may be formed from Nitinolor other elastic or superelastic material, such that the loop 1154 maybe bent away from the post 1152 to the open position. The retainingmember 1160 may include a lumen 1162 or other recess for receiving theloop 1154 in the open position, thereby constraining the loop 1154.

Turning to FIGS. 39A and 39C, during use, the gasket member 1112 may beintroduced into and secured to the biological annulus (not shown),similar to the previous embodiments, with the retaining member(s) 1160retaining the latch(es) 1150 in the open position. Although only asingle latch 1150 and retaining member 1160 are shown, it will beappreciated that a plurality of latches 1150 may be provided around thecircumference of the gasket member 1112, with each latch 1150 having acorresponding retaining member 1160. A valve member 1114 may includereceiving elements 1138 (one shown) through which respective retainingmembers 1160 may pass as the valve member 1114 is directed towards thegasket member 1112, as shown in FIG. 39A. Once the valve member 1114 isdisposed adjacent the gasket member 1112, as shown in FIG. 39B, theretaining member 1160 may be withdrawn, releasing the latch 1150. Theloop 1154 may resiliently pivot to the closed position surrounding thepost 1152, thereby substantially securing the valve member 1014 to thegasket member 1012.

Turning to FIGS. 40A-40B, another embodiment of a clip 1250 is shownthat includes a plurality of transverse elements 1252 defining anopening 1254 therein. As shown, the clip 1250 includes four transverseelements 1252 defining a diamond shape, although it will be appreciatedthat other shapes, including fewer or additional transverse elements(not shown), may also be provided. The clip 1250 is compressible to afirst position, i.e., wherein the clip 1250 is deformed inwardly in agenerally horizontal direction, whereby the clip 1250 may elongatevertically, as best seen in FIG. 40A. The clip 1250 may be biasedtowards a second position, i.e., wherein the clip 1250 widens andshortens, as shown in FIG. 40B.

To constrain the clip 1250 in the first position, a retaining member1260 may be provided, similar to the previous embodiments, that includesa lumen 1262 for receiving the clip 1250 therein. Unlike previousembodiments, the retaining member 1260 includes a slot 1264 at its lowerend that may be aligned with the opening 1254 in the clip 1250, as shownin FIG. 40A. For example, with the slot 1264 aligned with the opening1254, the clip 1250 may be compressed and inserted into the lumen 1262of the retaining member 1260. Because of the bias of the clip 1250, thetransverse elements 1252 may bear against the inner wall of theretaining member 1260, yet allow the clip 1250 to slide along the innerwall when the retaining member 1260 is withdrawn. Once released from theretaining member 1260, the clip 1250 may resiliently widen and shorten.

Turning to FIG. 41, a plurality of clips 1250 may be provided on agasket member 1212, which may be similar to any of the embodimentsdescribed herein. Initially, the clips 1250 may be constrained withinrespective retaining elements 1260 (shown in phantom for clarity). Thegasket member 1212 may be introduced and implanted within a biologicalannulus, similar to previous embodiments. Thereafter, a valve member1214, which may be similar to any of the embodiments described herein,may be introduced and advanced towards the gasket member 1212. The valvemember 1214 may include a plurality of buttons or catches 1238 disposedabout a circumference of the valve member 1214, e.g., corresponding tolocations of respective clips 1250 on the gasket member 1212. Analternative embodiment of a catch 1238′ that may be provided on thevalve member 1214′ is shown in FIG. 43.

Turning to FIG. 42A, as the valve member 1214 is directed towards thegasket member 1212, the catch 1238 may be received in the slot 1264 of arespective retaining member 1260, thereby aligning the catch 1238 withinthe opening 1254 of the clip 1250. Once the catch 1238 is received inthe opening 1254, the retaining member 1260 may be withdrawn, as shownin FIG. 42B, whereupon the clip 1250 may shorten, thereby capturing thecatch 1238 therein. The resulting compressive force from the clip 1250may direct the valve member 1214 further towards the gasket member 1212,thereby resisting the valve member 1214 being separated from the gasketmember 1212.

Turning to FIGS. 44-46, yet another embodiment of a heart valve assembly1310 is shown that includes a gasket member 1312 and a crown 1314.Similar to the previous embodiments, the gasket member 1312 may includean annular ring 1318 and a sewing cuff or ring 1320. The sewing cuff1320 may include a flexible core 1360 and a fabric covering 1370,similar to previous embodiments, and a baleen element 1330 may beprovided between the annular member 1318 and fabric covering 1370, alsosimilar to previous embodiments. The crown 1314 may include a frame 1332and a plurality of leaflets 1333 carried by struts 1335, also similar toprevious embodiments. In addition, similar to previous embodiments, thegasket member 1312 and/or crown 1314 may include one or more connectorsfor securing the crown 1314 relative to the gasket member 1312.

For example, as shown in FIGS. 44 and 46, the gasket member 1312 mayinclude a plurality of pockets 1350 that capture or otherwise secure oneor more regions of the crown 1314. As best seen in FIG. 46, each pocket1350 may include an outer wall 1352 and a cover 1354, thereby defining arecess 1356. The pockets 1350 may be integrally formed with the core1360 of the sewing cuff 1320, e.g., from a base 1362 of the core 1360.For example, the pockets 1350 and core 1360 may be molded or otherwiseformed from silicone or other flexible or semi-rigid material.Alternatively, the pockets 1350 may be formed separately and attached tothe base 1362, e.g., by bonding, heat fusion, interlocking connectors(not shown), and the like. The pockets 1350 may be sufficiently flexibleto be directed radially outwardly, e.g., to facilitate receiving thevalve member 1314 (as explained below), yet sufficiently resilient toreturn to its original position upon release.

During use, the gasket member 1312 may be implanted within a tissueannulus, similar to the methods and materials described elsewhereherein. The valve member 1314 may be introduced into the tissue annulus,e.g., into the sinus cavity above a native tissue valve site (notshown), with the frame 1332 angled diagonally relative to the gasketmember 1312. The frame 1332 may be directed under the pockets 1350 suchthat a portion of the frame 1332 is received within the recesses 1356.For example, first two lobes of the valve member 1314 may be directedinto two of the pockets 1350, which may cause the pockets 1350 to bedeflected slightly to facilitate insertion. Then, the remaining pocket1350 may be deflected outwardly, while the valve member 1314 is directedhorizontally against the sewing cuff 1320 of the gasket member 1312. Thedeflected pocket 1350 may then be released such that the cover 1354passes over the frame 1332 of the valve member 1314. Thus, the frame1332 is secured within the recesses 1356 below the covers 1354.

Optionally, as shown in FIG. 46, the gasket member 1312 may include arim 1364 that extends vertically from the base 1362, thereby at leastpartially defining a space 1365. A lower edge 1334 of the frame 1332 ofthe valve member 1314 maybe received in the space 1365, e.g., similar tothe embodiments described above. The frame 1332 may bear against the rim1364, e.g., to provide an interference fit, thereby further securing thevalve member 1314 relative to the gasket member 1312. Optionally, otherconnectors (not shown) may be provided in addition to or instead of thepockets 1350 and/or rim 1364.

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. A heart valve assembly, comprising: an annular prosthesis implantablewithin a natural valve annulus, the annulus prosthesis comprising anannular member for dilating tissue surrounding the annulus; a prostheticvalve comprising a multiple lobular shape for implantation above thenatural valve annulus; one or more connectors for securing theprosthetic valve to the annular prosthesis; and a flexible skirtextending radially from at least one of the annular prosthesis and theprosthetic valve for enhancing a seal between the prosthetic valve andthe annular prosthesis.
 2. The heart valve assembly of claim 1, whereinthe annular member has a substantially circular shape.
 3. The heartvalve assembly of claim 1, the flexible skirt comprising a sewing cuffextending radially outwardly from the annular member.
 4. The heart valveassembly of claim 3, the sewing cuff being resiliently flexible forconforming to the multiple lobular shape of the prosthetic valve toenhance a seal between the prosthetic valve and the annular prosthesis.5. The heart valve assembly of claim 3, the sewing cuff comprising acore resiliently conformable with anatomy surrounding the biologicalannulus and fabric covering at least a portion of the core.
 6. The heartvalve assembly of claim 5, wherein the core comprises one or morecircumferential elements extending around the circumference and aplurality of transverse elements extending transversely from the one ormore circumferential elements.
 7. The heart valve assembly of claim 5,wherein the core comprises a plurality of flexible ribs extendingupwardly.
 8. The heart valve assembly of claim 5, wherein the sewingcuff defines a tapered frusto-conical shape in a relaxed state, the corebeing sufficiently flexible that the shape of the sewing cuff changes asthe annular member is delivered into the tissue annulus.
 9. The heartvalve assembly of claim 8, wherein at least a portion of the sewing cuffbecomes more horizontal and another portion of the sewing cuff becomesmore vertical when the shape of the sewing cuff changes.
 10. The heartvalve assembly of claim 1, wherein the one or more connectors comprise aplurality of clips receivable through a portion of the prosthetic valveand the sewing cuff.
 11. The heart valve assembly of claim 1, whereinthe one or more connectors comprise a clip on the annular prosthesis forreceiving a portion of the prosthetic valve thereunder.
 12. The heartvalve assembly of claim 1, wherein the one or more connectors comprise aplurality of magnets on the annular member and the prosthetic valve. 13.The heart valve assembly of claim 1, wherein the prosthetic valvecomprises three lobes.
 14. A method for implanting a prosthetic heartvalve assembly to replace a natural or prosthetic heart valve implantedwithin a biological annulus below a sinus cavity, the method comprising:introducing an annular member into the biological annulus such that asewing cuff extending from the annular member is disposed within thesinus cavity; implanting the annular member within the biologicalannulus by directing a plurality of fasteners through the sewing cuffinto tissue adjacent the biological annulus; advancing amultiple-lobular valve prosthesis into the sinus cavity; and securingthe valve prosthesis relative to the annular member.
 15. The method ofclaim 14, wherein the annular member is rotationally aligned as it isintroduced into the biological annulus to align an undulation in theannular member above an underlying tissue structure.
 16. The method ofclaim 14, wherein the annular member is rotationally aligned as it isintroduced to align an ear extending from the sewing cuff with an RC/NCcommissure within the sinus cavity.
 17. The method of claim 14, whereina fabric covering extends radially outwardly from a lower edge of theannular member such that the fabric covering is disposed below thebiological annulus when the annular member is implanted.
 18. The methodof claim 17, wherein the annular member is radially contracted beforebeing introduced into the biological annulus, and wherein the annularmember is expanded by releasing the annular member, whereupon theannular member resiliently expands within the biological annulus to atleast partially dilate the biological annulus.
 19. The method of claim17, wherein the annular member comprises a fabric covering, at least aportion of which is biased radially outwardly away from the annularmember, the outwardly biased portion extending below the biologicalannulus when the annular member is implanted, thereby enhancing a sealbetween the outwardly biased portion and surrounding tissue below thebiological annulus.
 20. A method for implanting a prosthetic heart valveassembly to replace a natural or prosthetic heart valve implanted withina biological annulus below a sinus cavity, the method comprising:introducing an annular prosthesis into the biological annulus such thata sewing cuff extending from the annular prosthesis is disposed withinthe sinus cavity; implanting the annular prosthesis within thebiological annulus by directing a plurality of fasteners through thesewing cuff into tissue adjacent the biological annulus; introducing amultiple-lobular valve prosthesis into the sinus cavity; orienting thevalve prosthesis diagonally relative to the annular prosthesis such thatone or more lobes of the valve prosthesis are received under one or moreconnectors extending from the annular prosthesis; and directing thevalve prosthesis substantially horizontally against the annularprosthesis such that one or more additional lobes of the valveprosthesis are received under the one or more connectors to secure thevalve prosthesis relative to the annular prosthesis.